75% ALCOHOL HAND SANITIZER- alcohol gel

75% alcohol hand sanitizer by

Drug Labeling and Warnings

75% alcohol hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Narwhal, Inc., Aogrand International Trade Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic. Hand senitizer

Uses

Hand sanitizer to help decrease bacteria on the skin when water, soap, and towel are not available. Recommended for repeated use.

Directions

Place enough product into your palms and thoroughly spread on both hands.

Rub into skin until dry.

Children under 6 years old must be supervised using this product.

Avoid contact with eyes; in case of contact, flush with water.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

DO NOT USE

Do not apply around eyes. Do not use in ears & mouth.

STOP USE

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center immediately.

Inactive ingredients

Carbomer, triethanolamine, glycerin, water

OTHER SAFETY INFORMATION

Store below 110°F (43°C). May discolor certain fabrics or surfaces.

Package Label - Principal Display Panel

237 mL NDC: 78615-001-01

500 mL NDC: 78615-001-02

1000 mL NDC: 78615-001-03

INGREDIENTS AND APPEARANCE

75% ALCOHOL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78615-001(NDC:74621-010)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78615-001-01	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
2	NDC: 78615-001-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
3	NDC: 78615-001-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/31/2020

Labeler - Narwhal, Inc. (102299663)

Registrant - Aogrand International Trade Corporation (421353092)