HAND SANITIZER- alcohol gel 
Kepter Mexico S.A de C.V

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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Hand Sanitizer

This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

a. Alcohol (ethanol) (USP of Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

b. Glycerin (.5% v/v).

c. Carbopol (.5% v/v).

d. Triethanolamine (.4% v/v).

e. Sterile distilled water or boiled cold water.

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Antiseptic Hand Sanitizer to reduce germs on the skin. For use when soap and water not available.

Warnings

For external use only. Flammable. Keep away from open flame and sources of heat.

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 doctor: If irritation, rash or redness ocurrs. These may be signs of a serious condition.

Keep out reach of children: If swallowed, get medical help or contat a Posion Control Center right away.

Stop use and ask doctor: If irritation, rash or redness occurs. These may be signs of a serious condition.

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

Directions

Apply a small amount of product into hands and rub between both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store below 110F (43C)

Avoid freezing. May discolor certain fabrics/surfaces.

Inactive Ingredients

Water, Glycerin, Carbopol, Triethanolamine

Package Label - Principal Display Panel

976 ml NDC: 78391-001-01

1 lt kepter

3786 ml NDC: 78391-001-02

gal kepter

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78391-001
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
WATER (UNII: 059QF0KO0R) 28 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.4 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.5 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78391-001-01976 mL in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
2NDC:78391-001-023786 mL in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/29/2020
Labeler - Kepter Mexico S.A de C.V (812889284)
Establishment
NameAddressID/FEIBusiness Operations
Kepter Mexico S.A de C.V812889284manufacture(78391-001)

Revised: 6/2020
Document Id: a8c8b491-55ef-22e0-e053-2995a90ac5f2
Set id: a6e158dc-731e-7c32-e053-2a95a90a65b7
Version: 5
Effective Time: 20200623
 
Kepter Mexico S.A de C.V