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 
EARTH TO SKIN SCENT FREE HAND SANITIZER 2.0 OZ- alcohol gel 
COSMAX USA, INC. (COSMAX USA, CORPORATION)

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.

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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 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 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.

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

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
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 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
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 Product07/17/202012/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/17/202012/31/2022
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
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
EUGENOL (UNII: 3T8H1794QW) 0.0011988 mL  in 100 mL
COCONUT JUICE (UNII: AMN6S4M09G) 0.00015 mL  in 100 mL
BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.0135 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 Product07/17/202012/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/17/202012/31/2022
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
LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.00352 mL  in 100 mL
BENZYL CINNAMATE (UNII: V67O3RO97U) 0.00122 mL  in 100 mL
LOWBUSH BLUEBERRY (UNII: G90PX41VP0) 0.0005 mL  in 100 mL
BENZYL BENZOATE (UNII: N863NB338G) 0.10132 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 Product07/17/202012/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/17/202012/31/2022
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 Product07/17/202012/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/17/202012/31/2022
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
GLYCERIN (UNII: PDC6A3C0OX) 0.01 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
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69323-209-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product07/17/202012/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/17/202012/31/2022
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)

Revised: 7/2023
Document Id: 0185b198-0217-c7fa-e063-6394a90ab843
Set id: aa945c81-e375-403f-e053-2a95a90a6647
Version: 2
Effective Time: 20230728
 
COSMAX USA, INC. (COSMAX USA, CORPORATION)