75% ALCOHOL HAND SANITIZER- alcohol gel 
Narwhal, Inc.

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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75% alcohol hand sanitizer

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

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

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

Inactive ingredients

Carbomer, triethanolamine, glycerin, water

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

Package Label - Principal Display Panel

237 mL NDC: 78615-001-01

PDP

500 mL NDC: 78615-001-02

PDP

1000 mL NDC: 78615-001-03

PDP

75% ALCOHOL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78615-001(NDC:74621-010)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID (UNII: J94PBK7X8S)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78615-001-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
2NDC:78615-001-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
3NDC:78615-001-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/31/2020
Labeler - Narwhal, Inc. (102299663)
Registrant - Aogrand International Trade Corporation (421353092)

Revised: 2/2023
Document Id: f48fa482-28a2-307f-e053-2995a90a3bca
Set id: a714b7a3-b1f4-2fbe-e053-2a95a90a3e48
Version: 4
Effective Time: 20230213
 
Narwhal, Inc.