HAND SANITIZER- alcohol gel

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by COMERCIAL GOURA,S. DE R.L.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIRECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry.

INACTIVE INGREDIENT SECTION

Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

INDICATIONS AND USAGE

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.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE SECTION

Purpose

Antmicrobial

WARNINGS AND PRECAUTIONS

Warnings

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Store below 110°F (43°C)

ACTIVE INGREDIENT

Active ingredient. Ethyl Alcohol 70% v/v

ASK A DOCTOR

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

ASK A DOCTOR

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

WARNING

Warnings

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

PACKAGE LABELS

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78501-1000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)	0.002 mL  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.0375 mL  in 1 mL
WATER (UNII: 059QF0KO0R)	0.2585 mL  in 1 mL
TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253)	0.002 mL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78501-1000-4	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2020
2	NDC: 78501-1000-5	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2020
3	NDC: 78501-1000-6	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2020
4	NDC: 78501-1000-7	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/26/2020

Labeler - COMERCIAL GOURA,S. DE R.L. (951578628)

Registrant - COMERCIAL GOURA,S. DE R.L. (951578628)

Establishment
Name	Address	ID/FEI	Business Operations
COMERCIAL GOURA,S. DE R.L.		951578628	manufacture(78501-1000)