Label: STAYCLEAN SCENTED HAND GEL SANITIZER BLUEBERRY 2 FL.OZ- alcohol gel
STAYCLEAN SCENTED HAND GEL SANITIZER COCONUT 8 FL.OZ- alcohol gel
STAYCLEAN SCENTED HAND GEL SANITIZER BLUEBERRY 8 FL.OZ- alcohol gel
EARTH TO SKIN WATERMELON HAND SANITIZER 2.0 OZ- alcohol gel
EARTH TO SKIN LEMON BASIL HAND SANITIZER 2.0 OZ- alcohol gel
EARTH TO SKIN BLUEBERRY HAND SANITIZER 2.0 OZ- alcohol gel
EARTH TO SKIN SCENT FREE HAND SANITIZER 2.0 OZ- alcohol gel
EARTH TO SKIN COCONUT ALOE HAND SANITIZER 2.0 OZ- alcohol gel
STAYCLEAN SCENTED HAND GEL SANITIZER WATERMELON 2 FL.OZ- alcohol gel
STAYCLEAN SCENTED HAND GEL SANITIZER WATERMELON 8 FL.OZ- alcohol gel
STAYCLEAN SCENTED HAND GEL SANITIZER LEMON CITRUS 2 FL.OZ- alcohol gel
STAYCLEAN SCENTED HAND GEL SANITIZER LEMON CITRUS 8 FL.OZ- alcohol gel
STAYCLEAN SCENTED HAND GEL SANITIZER COCONUT 2 FL.OZ- alcohol gel

  • NDC Code(s): 68577-006-00, 68577-007-00, 68577-008-00, 68577-009-00, view more
    68577-010-00, 68577-022-00, 68577-023-00, 68577-024-00, 68577-025-00, 68577-026-00, 68577-027-00, 68577-028-00, 68577-029-00
  • Packager: Nu-World Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 14, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.45% v/v).
    3. Hydrogen peroxide (0.125% v/v).
    4. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Alcohol 72% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients-Earth To Skin Scent Free Hand Sanitizer 2.0 OZ

    Water, Butylene Glycol,Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate,Carbomer, Aminomethyl Propanol, Ethyl Hexanediol, Phenoxyethanol

  • Inactive Ingredients-Earth To Skin Blueberry Hand Sanitizer 2.0 OZ

    Water,Vaccinium Angustifolium (Blueberry) Fruit Extract, Aloe Barbadensis Leaf Juice,Butylene Glycol, Glycerin, Propanediol, Isopropyl Myristate,Carbomer, Aminomethyl Propanol, Fragrance(Parfum), Benzyl Benzoate,Benzyl Alcohol,Linalool,Benzyl Cinnamate, Ethyl Hexanediol, Phenoxyethanol

  • Inactive Ingredient-Earth To Skin Watermelon Hand Sanitizer 2.0 OZ

    Water, Citrullus Lanatus (Watermelon) Fruit Extract, Aloe Barbadensis Leaf Juice, Glycerin, Butylene Glycol, Isopropyl Myristate,
    Carbomer, Aminomethyl Propanol, Fragrance(Parfum), Limonene, Benzyl Alcohol, Leuconostoc/Radish Root Ferment Filtrate, Ethyl Hexanediol, Phenoxyethanol

  • Inactive Ingredient-Earth To Skin Lemon + Basil Hand Sanitizer 2.0 OZ

    Water, Lactobacillus/Lemon Peel Ferment Extract, Ocimum Basilicum (Basil) Oil, Aloearbadensis Leaf Juice, Butylene Glycol, Glycerin, Ethylhexyl Palmitate, Isopropyl Myristate, Carbomer, Aminomethyl Propanol, Fragrance(Parfum), Citral, Hexyl Cinnamal, Limonene, Ethyl Hexanediol, Phenoxyethanol

  • Inactive Ingredient-Earth To Skin Coconut + Aloe Hand Sanitizer 2.0 OZ

    Water, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Water, Cocos Nucifera (Coconut) Fruit Juice,Glycerin, Butylene Glycol, Isopropyl Myristate, Carbomer, Aminomethyl Propanol, Fragrance(Parfum), Limonene, Eugenol, Ethyl Hexanediol, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate

  • Inactive Ingredient-StayClean Scented Hand Gel Sanitizer Blueberry 2 FL.OZ

    Water, Carbomer, Benzyl Benzoate, Fragrance(Parfum), Aminomethyl Propanol,Benzyl Alcohol, Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Propanediol, Linalool, Benzyl Cinnamate, Isopropyl Myristate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Ethyl Hexanediol, Phenoxyethanol

  • Inactive Ingredient-StayClean Scented Hand Gel Sanitizer Blueberry 8 FL.OZ

    Water, Carbomer, Benzyl Benzoate, Fragrance(Parfum), Aminomethyl Propanol,Benzyl Alcohol, Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Propanediol, Linalool, Benzyl Cinnamate, Isopropyl Myristate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Ethyl Hexanediol, Phenoxyethanol

  • Inactive Ingredient-StayClean Scented Hand Gel Sanitizer Watermelon 2 FL.OZ

    Water, Carbomer, Fragrance(Parfum), Aminomethyl Propanol,Glycerin, Butylene Glycol,Aloe Barbadensis Leaf Juice,Limonene, Benzyl Alcohol,Citrullus Lanatus (Watermelon) Fruit Extract, Isopropyl Myristate, Leuconostoc/Radish Root Ferment Filtrate, Ethyl Hexanediol, Phenoxyethanol

  • Inactive Ingredient-StayClean Scented Hand Gel Sanitizer Watermelon 8 FL.OZ

    Water, Carbomer, Fragrance(Parfum), Aminomethyl Propanol,Glycerin, Butylene Glycol,Aloe Barbadensis Leaf Juice,Limonene, Benzyl Alcohol,Citrullus Lanatus (Watermelon) Fruit Extract, Isopropyl Myristate, Leuconostoc/Radish Root Ferment Filtrate, Ethyl Hexanediol, Phenoxyethanol

  • Inactive Ingredient-StayClean Scented Hand Gel Sanitizer Lemon Citrus 2 FL.OZ

    Water, Carbomer, Fragrance(Parfum),Limonene, Aminomethyl Propanol, Citral, Hexyl Cinnamal, Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Ethylhexyl Palmitate, Lactobacillus/Lemon Peel Ferment Extract, Isopropyl Myristate, Ocimum Basilicum (Basil) Oil, Ethyl Hexanediol, Phenoxyethanol

  • Inactive Ingredeint-StayClean Scented Hand Gel Sanitizer Lemon Citrus 8 FL.OZ

    Water, Carbomer, Fragrance(Parfum),Limonene, Aminomethyl Propanol, Citral, Hexyl Cinnamal, Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Ethylhexyl Palmitate, Lactobacillus/Lemon Peel Ferment Extract, Isopropyl Myristate, Ocimum Basilicum (Basil) Oil, Ethyl Hexanediol, Phenoxyethanol

  • Inactive Ingredient-StayClean Scented Hand Gel Sanitizer Coconut 2 FL.OZ

    Water, Carbomer, Fragrance(Parfum),Aminomethyl Propanol, Glycerin, Limonene, Butylene Glycol, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Water, Eugenol, Isopropyl Myristate, Cocos Nucifera (Coconut) Fruit Juice, Ethyl Hexanediol, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate

  • Inactive Ingredient-StayClean Scented Hand Gel Sanitizer Coconut 8 FL.OZ

    Water, Carbomer, Fragrance(Parfum),Aminomethyl Propanol, Glycerin, Limonene, Butylene Glycol, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Water, Eugenol, Isopropyl Myristate, Cocos Nucifera (Coconut) Fruit Juice, Ethyl Hexanediol, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate

  • Package Label - Principal Display Panel-Earth To Skin Scent Free Hand Sanitizer 2.0 OZ Front

    Packaging Label-Scent Free  Front Label60 mL NDC: 68577-006-00

  • Package Label.Principal Display Panel-Earth To Skin Scent Free Hand Sanitizer 2.0 OZ Back

    1Packaging Label Scent Free-Back Label


    1
    60ML NDC:68577-006-00
  • Package Label. Principal Display Panel-Earth To Skin Blueberry Hand Sanitizer 2.0 OZ Front

    Packaging Label-Blueberry Font Label60ml NDC: 68577-007-00

  • Package Label. Principal Display Panel-Earth To Skin Blueberry Hand Sanitizer 2.0 OZ Back

    Packaging Label-Blueberry Back Label 60ML NDC: 68577-007-00

  • Packag Labl. Principal Dispaly Panel-Earth To Skin Watermelon Hand Sanitizer 2.0 OZ Front

    Package Label-Watermelon Front Label60ML NDC:68577-008-00

  • Package Label. Principal Display-Earth To Skin Watermelon Hand Sanitizer 2.0 OZ Back

    Package Label-Watermelon Back Label60ML NDC:68577-008-00

  • Packaging Label. Principal Display Panel-Earth To Skin Coconut + Aloe Hand Sanitizer 2.0 OZ Front

    Packaging Label-Coconut + Aloe Front Label

    60ML NDC:68577-01-00

  • Package Label. Principal Display Panel-Earth To Skin Coconut + Aloe Hand Sanitizer 2.0 OZ Back

    Package Label-Coconut + Aloe Back Label

    60ML NDC:68577-010-00

  • Package Label. Principal Display Panel-Earth To Skin Lemon + Basil Hand Sanitizer 2.0 OZ Front

    60ML NDC:68577-009-00

    Package Label-Lemon + Basil Front Label

  • Package Label. Principal Display Panel-Earth To Skin Lemon + Basil Hand Sanitizer 2.0 OZ Back

    60ML NDC:68577-009-00

    Package Label-Lemon + Basil Back Label

  • Package Label. Principal Display Panel-StayClean Scented Hand Gel Sanitizer Blueberry 2 FL.OZ

    Packaging Label-StayClean Scented Hand Gel Sanitizer Blueberry 2 FL.OZ59ml, NDC:68577-022-00

  • Package Label. Principal Display Panel-StayClean Scented Hand Gel Sanitizer Blueberry 8 FL.OZ

    Packaging Label-StayClean Scented Hand Gel Sanitizer Blueberry 8 FL.OZ236ml, NDC: 68577-023-00

  • Package Label. Principal Display Panel-StayClean Scented Hand Gel Sanitizer Watermelon 2 FL.OZ

    Package label-StayClean Scented Hand Gel Sanitizer Watermelon 2 FL.OZ59ml, NDC: 68577-024-00

  • Package Label. Principal Display-StayClean Scented Hand Gel Sanitizer Watermelon 8 FL.OZ

    Packaging Label-StayClean Scented Hand Gel Sanitizer Watermelon 8 FL.OZ236ml, NDC: 68577-025-00

  • Package Label. Principal Display Panel-StayClean Scented Hand Gel Sanitizer Lemon Citrus 2 FL.OZ

    Packaging Label-StayClean Scented Hand Gel Sanitizer Lemon Citrus 2 FL.OZ59ml, NDC:68577-026-00

  • Package Label. Principal Display Panel-StayClean Scented Hand Gel Sanitizer Lemon Citrus 8 FL.OZ

    Packaging Label-StayClean Scented Hand Gel Sanitizer Lemon Citrus 8 FL.OZ236ml, NDC: 68577-027-00

  • Package Label. Principal Display Panel-StayClean Scented Hand Gel Sanitizer Coconut 2 FL.OZ

    Packaging Label-StayClean Scented Hand Gel Sanitizer Coconut  2 FL.OZ59ml, NDC: 68577-028-00

  • Package Label. Principal Display Panel-StayClean Scented Hand Gel Sanitizer Coconut 8 FL.OZ

    Packaging Label-StayClean Scented Hand Gel Sanitizer Coconut  8 FL.OZ236ml, NDC:68577-029-00

  • INGREDIENTS AND APPEARANCE
    STAYCLEAN SCENTED HAND GEL SANITIZER BLUEBERRY 2 FL.OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.00352 mL  in 100 mL
    BENZYL CINNAMATE (UNII: V67O3RO97U) 0.00122 mL  in 100 mL
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.44597 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
    BENZYL BENZOATE (UNII: N863NB338G) 0.10132 mL  in 100 mL
    PROPANEDIOL (UNII: 5965N8W85T) 0.0095 mL  in 100 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.01306 mL  in 100 mL
    LOWBUSH BLUEBERRY (UNII: G90PX41VP0) 0.0005 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-022-0059 mL in 1 BOTTLE; Type 0: Not a Combination Product08/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/29/2020
    STAYCLEAN SCENTED HAND GEL SANITIZER COCONUT 8 FL.OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-029
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUGENOL (UNII: 3T8H1794QW) 0.0011988 mL  in 100 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.013294 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.44597 mL  in 100 mL
    COCONUT WATER (UNII: 267F5Y81NT) 0.00628 mL  in 100 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.00002 mL  in 100 mL
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.0135 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.00005 mL  in 100 mL
    COCONUT JUICE (UNII: AMN6S4M09G) 0.00015 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-029-00236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/29/2020
    STAYCLEAN SCENTED HAND GEL SANITIZER BLUEBERRY 8 FL.OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.00352 mL  in 100 mL
    BENZYL CINNAMATE (UNII: V67O3RO97U) 0.00122 mL  in 100 mL
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.44597 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
    BENZYL BENZOATE (UNII: N863NB338G) 0.10132 mL  in 100 mL
    PROPANEDIOL (UNII: 5965N8W85T) 0.0095 mL  in 100 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.01306 mL  in 100 mL
    LOWBUSH BLUEBERRY (UNII: G90PX41VP0) 0.0005 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-023-00236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/29/2020
    EARTH TO SKIN WATERMELON HAND SANITIZER 2.0 OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.0178 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.44597 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.0064532 mL  in 100 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.003967 mL  in 100 mL
    WATERMELON (UNII: 231473QB6R) 0.002 mL  in 100 mL
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) 0.0002 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-008-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    EARTH TO SKIN LEMON BASIL HAND SANITIZER 2.0 OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.44497 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
    CITRAL (UNII: T7EU0O9VPP) 0.01092882 mL  in 100 mL
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) 0.01018 mL  in 100 mL
    LEMON PEEL (UNII: 72O054U628) 0.002 mL  in 100 mL
    BASIL OIL (UNII: Z129UMU8LE) 0.00099636 mL  in 100 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.07050642 mL  in 100 mL
    ETHYLHEXYL PALMITATE (UNII: 2865993309) 0.008 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-009-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    EARTH TO SKIN BLUEBERRY HAND SANITIZER 2.0 OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.00352 mL  in 100 mL
    BENZYL CINNAMATE (UNII: V67O3RO97U) 0.00122 mL  in 100 mL
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.44597 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
    BENZYL BENZOATE (UNII: N863NB338G) 0.10132 mL  in 100 mL
    PROPANEDIOL (UNII: 5965N8W85T) 0.0095 mL  in 100 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.01306 mL  in 100 mL
    LOWBUSH BLUEBERRY (UNII: G90PX41VP0) 0.0005 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-007-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    EARTH TO SKIN SCENT FREE HAND SANITIZER 2.0 OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.65597 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-006-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    EARTH TO SKIN COCONUT ALOE HAND SANITIZER 2.0 OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUGENOL (UNII: 3T8H1794QW) 0.0011988 mL  in 100 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.013294 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.44597 mL  in 100 mL
    COCONUT WATER (UNII: 267F5Y81NT) 0.00628 mL  in 100 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.00002 mL  in 100 mL
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.0135 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.00005 mL  in 100 mL
    COCONUT JUICE (UNII: AMN6S4M09G) 0.00015 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-010-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    STAYCLEAN SCENTED HAND GEL SANITIZER WATERMELON 2 FL.OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.0178 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.44597 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.0064532 mL  in 100 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.003967 mL  in 100 mL
    WATERMELON (UNII: 231473QB6R) 0.002 mL  in 100 mL
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) 0.0002 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-024-0059 mL in 1 BOTTLE; Type 0: Not a Combination Product08/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/29/2020
    STAYCLEAN SCENTED HAND GEL SANITIZER WATERMELON 8 FL.OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.0178 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.44597 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.0064532 mL  in 100 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.003967 mL  in 100 mL
    WATERMELON (UNII: 231473QB6R) 0.002 mL  in 100 mL
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) 0.0002 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-025-00236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/29/2020
    STAYCLEAN SCENTED HAND GEL SANITIZER LEMON CITRUS 2 FL.OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-026
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.44497 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
    CITRAL (UNII: T7EU0O9VPP) 0.01092882 mL  in 100 mL
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) 0.01018 mL  in 100 mL
    LEMON PEEL (UNII: 72O054U628) 0.002 mL  in 100 mL
    BASIL OIL (UNII: Z129UMU8LE) 0.00099636 mL  in 100 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.07050642 mL  in 100 mL
    ETHYLHEXYL PALMITATE (UNII: 2865993309) 0.008 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-026-0059 mL in 1 BOTTLE; Type 0: Not a Combination Product08/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/29/2020
    STAYCLEAN SCENTED HAND GEL SANITIZER LEMON CITRUS 8 FL.OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.44497 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
    CITRAL (UNII: T7EU0O9VPP) 0.01092882 mL  in 100 mL
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) 0.01018 mL  in 100 mL
    LEMON PEEL (UNII: 72O054U628) 0.002 mL  in 100 mL
    BASIL OIL (UNII: Z129UMU8LE) 0.00099636 mL  in 100 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.07050642 mL  in 100 mL
    ETHYLHEXYL PALMITATE (UNII: 2865993309) 0.008 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-027-00236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/29/2020
    STAYCLEAN SCENTED HAND GEL SANITIZER COCONUT 2 FL.OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-028
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUGENOL (UNII: 3T8H1794QW) 0.0011988 mL  in 100 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.013294 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.44597 mL  in 100 mL
    COCONUT WATER (UNII: 267F5Y81NT) 0.00628 mL  in 100 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.00002 mL  in 100 mL
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.0135 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.00005 mL  in 100 mL
    COCONUT JUICE (UNII: AMN6S4M09G) 0.00015 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-028-0059 mL in 1 BOTTLE; Type 0: Not a Combination Product08/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/29/2020
    Labeler - Nu-World Corporation (628045858)
    Registrant - Nu-World Corporation (628045858)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nu-World Corporation628045858manufacture(68577-006, 68577-007, 68577-008, 68577-009, 68577-010, 68577-022, 68577-023, 68577-024, 68577-025, 68577-026, 68577-027, 68577-028, 68577-029)