Hand San Gel by Dubois Chemicals, Inc. Hand San Gel

Hand San Gel by

Drug Labeling and Warnings

Hand San Gel by is a Otc medication manufactured, distributed, or labeled by Dubois Chemicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SAN GEL- alcohol gel 
Dubois Chemicals, 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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Hand San Gel

Active Ingredient(s)

Alcohol 66% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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.

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

water, glycerol, hydroxypropyl methylcellulose, hygrogen peroxide

Package Label - Principal Display Panel

HAND SAN GEL

Hand Sanitizer

000.00 mL (00 oz.) / 000 L (00 U.S. GAL)

SKU:

LOT NUMBER:

DuBois Chemicals, Inc. Cincinnati, OH 45241-2046

MADE IN USA

HAND SAN GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44395-1114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.066 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44395-1114-2	3.78 L in 1 JUG; Type 0: Not a Combination Product	08/10/2020	12/30/2022
2	NDC: 44395-1114-1	0.47316 L in 1 BOTTLE; Type 0: Not a Combination Product	08/10/2020	12/30/2022
3	NDC: 44395-1114-3	18.9 L in 1 DRUM; Type 0: Not a Combination Product	08/10/2020	12/30/2022
4	NDC: 44395-1114-4	208.2 L in 1 DRUM; Type 0: Not a Combination Product	08/10/2020	12/30/2022
5	NDC: 44395-1114-5	1249.2 L in 1 DRUM; Type 0: Not a Combination Product	08/10/2020	12/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2020	12/30/2022

Labeler - Dubois Chemicals, Inc. (828235445)

Establishment
Name	Address	ID/FEI	Business Operations
Dubois Chemicals, Inc.		828235445	manufacture(44395-1114) , pack(44395-1114) , label(44395-1114)

Revised: 1/2022

Document Id: d5df0080-3137-e8c7-e053-2a95a90aa130

34390-5

Set id: ac8b9f4a-40ba-932e-e053-2995a90adc41

Version: 2

Effective Time: 20220118