AGACHY FAST CLEAN HAND SANITIZER- hand sanitizer gel 
ICOMAX Co., Ltd.

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 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

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

When using this product do not use in or near the eye. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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

Directions

Other information

Inactive ingredients

Water, Butylene Glycol, Glycerin, Carbomer, Triethanolamine, Menthol, Aloe Barbadensis Leaf, Sodium Hyaluronate, 1,2-Hexanediol

Package Label - Principal Display Panel

500 mL NDC: 77201-002-50 500 mL NDC: 77201-002-50

AGACHY FAST CLEAN HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77201-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
WATER (UNII: 059QF0KO0R)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77201-002-50500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/18/2020
Labeler - ICOMAX Co., Ltd. (694834031)
Establishment
NameAddressID/FEIBusiness Operations
ICOMAX Co., Ltd.694834031manufacture(77201-002)

Revised: 5/2020
Document Id: a6b194ef-820d-5190-e053-2a95a90acf58
Set id: a5a7d5d4-d740-119f-e053-2a95a90ad516
Version: 3
Effective Time: 20200528
 
ICOMAX Co., Ltd.