Label: EARTH TO SKIN SCENT FREE HAND SANITIZER 2.0 OZ- alcohol gel
EARTH TO SKIN WATERMELON HAND SANITIZER 2.0 OZ- alcohol gel
EARTH TO SKIN COCONUT ALOE HAND SANITIZER 2.0 OZ- alcohol gel
EARTH TO SKIN BLUEBERRY HAND SANITIZER 2.0 OZ- alcohol gel
EARTH TO SKIN LEMON BASIL HAND SANITIZER 2.0 OZ- alcohol gel

  • NDC Code(s): 69323-209-00, 69323-210-00, 69323-211-00, 69323-212-00, view more
    69323-213-00
  • Packager: COSMAX USA, INC. (COSMAX USA, 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 July 16, 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, Carbomer, Aminomethyl Propanol,Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Ethyl Hexanediol, Phenoxyethanol

  • Inactive Ingredient- Earth To Skin Blueberry Hand Sanitizer 2.0 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-Earth To Skin Watermelon Hand Sanitizer 2.0 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 -Earth To Skin Lemon Basil Hand Sanitizer 2.0 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-Earth To Skin Coconut Aloe Hand Sanitizer 2.0 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 Label

    Scent Free-front label60 mL NDC: 69323-209-00

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

    Scent Free-back label60 ml, NDC-69323-209-00

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

    Blueberry-Front Label60 ml, NDC:69323-210-00

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

    Blueberry-Back Label60ml, NDC:69323-210-00

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

    Watermelon-Front Label60ml, NDC: 69323-211-00

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

    Watermelon-Back Label60ml, NDC:69323-211-00

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

    Lemon Basil-Front Label 60ml, NDC:69323-212-00

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

    Lemon Basil-Back Label 60 ml, NDC: 69323-212-00

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

    Coconut Aloe-Front Label 60ml, NDC: 69323-213-00

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

    Coconut Aloe-Back Label 60ml, NDC: 69323-213-00

  • INGREDIENTS AND APPEARANCE
    EARTH TO SKIN SCENT FREE HAND SANITIZER 2.0 OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69323-209
    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
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.65597 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 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
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69323-209-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product07/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/17/2020
    EARTH TO SKIN WATERMELON HAND SANITIZER 2.0 OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69323-211
    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
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) 0.0002 mL  in 100 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.0064532 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.44597 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 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
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.0178 mL  in 100 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.003967 mL  in 100 mL
    WATERMELON (UNII: 231473QB6R) 0.002 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69323-211-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product07/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/17/2020
    EARTH TO SKIN COCONUT ALOE HAND SANITIZER 2.0 OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69323-213
    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
    COCONUT WATER (UNII: 267F5Y81NT) 0.00628 mL  in 100 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.00002 mL  in 100 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.00005 mL  in 100 mL
    COCONUT JUICE (UNII: AMN6S4M09G) 0.00015 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.013294 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.44597 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 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
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.0135 mL  in 100 mL
    EUGENOL (UNII: 3T8H1794QW) 0.0011988 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69323-213-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product07/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/17/2020
    EARTH TO SKIN BLUEBERRY HAND SANITIZER 2.0 OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69323-210
    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
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.44597 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 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
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL  in 100 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.01306 mL  in 100 mL
    PROPANEDIOL (UNII: 5965N8W85T) 0.0095 mL  in 100 mL
    LOWBUSH BLUEBERRY (UNII: G90PX41VP0) 0.0005 mL  in 100 mL
    LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.00352 mL  in 100 mL
    BENZYL BENZOATE (UNII: N863NB338G) 0.10132 mL  in 100 mL
    BENZYL CINNAMATE (UNII: V67O3RO97U) 0.00122 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69323-210-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product07/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/17/2020
    EARTH TO SKIN LEMON BASIL HAND SANITIZER 2.0 OZ 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69323-212
    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
    CITRAL (UNII: T7EU0O9VPP) 0.01092882 mL  in 100 mL
    BASIL OIL (UNII: Z129UMU8LE) 0.00099636 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL  in 100 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.07050642 mL  in 100 mL
    ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.44497 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
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL  in 100 mL
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) 0.01018 mL  in 100 mL
    ETHYLHEXYL PALMITATE (UNII: 2865993309) 0.008 mL  in 100 mL
    LEMON PEEL (UNII: 72O054U628) 0.002 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69323-212-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product07/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/17/2020
    Labeler - COSMAX USA, INC. (COSMAX USA, CORPORATION) (010990210)
    Registrant - COSMAX USA, INC. (COSMAX USA, CORPORATION) (010990210)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMAX USA, INC. (COSMAX USA, CORPORATION)010990210manufacture(69323-209, 69323-210, 69323-211, 69323-212, 69323-213)