Hand Sanitizer by Den-Mat Holdings, LLC

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Den-Mat Holdings, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
Den-Mat Holdings, LLC

----------

Drug Facts

Active Ingredient(s)

Alcohol 80% v/v

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

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 a doctor

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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.

Other information

■ Store between 15-30C (59-86F)
■ Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Package Label - Principal Display Panel

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59883-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
MINT (UNII: FV98Z8GITP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59883-303-05	5 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/08/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	10/08/2021	11/08/2021

Labeler - Den-Mat Holdings, LLC (809857704)

Establishment
Name	Address	ID/FEI	Business Operations
Den-Mat Holdings, LLC		809857704	manufacture(59883-303) , label(59883-303) , pack(59883-303)

Revised: 12/2023

Document Id: 0daf5bef-1f95-7c8b-e063-6294a90a82e7

34390-5

Set id: cef5b0d3-c154-801e-e053-2995a90a038a

Version: 2

Effective Time: 20231229