HAND SANITIZER 250ML- alcohol gel 
ABC INTERNATIONAL 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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Cool&Cool Hand Sanitizer Disinfectant 250ml

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 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

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

Other information

Inactive ingredients

aqua, Carbopol, PERFUME, VITAMIN E, GLYCERIN, Tri Ethanol Amine

Package Label - Principal Display Panel

250ml sanitizer Disinfectant250mL NDC: 77118-904-25

HAND SANITIZER  250ML
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77118-904
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL175 mL  in 250 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 5 mL  in 250 mL
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 0.0625 mL  in 250 mL
WATER (UNII: 059QF0KO0R) 67.5 mL  in 250 mL
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) 0.5 mL  in 250 mL
1,1,1-TRIETHOXYETHANE (UNII: 48352MHC78) 1.25 mL  in 250 mL
CARBOPLATIN (UNII: BG3F62OND5) 0.6875 mL  in 250 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77118-904-25250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - ABC INTERNATIONAL LTD (864324525)
Establishment
NameAddressID/FEIBusiness Operations
ABC INDUSTRIES LLC561180632api manufacture(77118-904)

Revised: 1/2021
Document Id: b980a957-1324-4b54-e053-2a95a90a47b9
Set id: b980a957-1332-4b54-e053-2a95a90a47b9
Version: 1
Effective Time: 20210122
 
ABC INTERNATIONAL LTD