HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kepter Mexico S.A de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

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

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

3786 ml NDC: 78391-001-02

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78391-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78391-001-01	976 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2020
2	NDC: 78391-001-02	3786 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/29/2020

Labeler - Kepter Mexico S.A de C.V (812889284)

Establishment
Name	Address	ID/FEI	Business Operations
Kepter Mexico S.A de C.V		812889284	manufacture(78391-001)