HAND SANITIZER GEL- alcohol gel

Hand Sanitizer Gel by

Drug Labeling and Warnings

Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Solvents and Petroleum Service, Inc., Clean All. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

72% Ethyl Alcohol

Purpose

Antiseptic, Hand Sanitizer

Use

Uses 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

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

STOP USE

STOP USE AND ASK A DOCTOR if irritation or rash occurs. These may be signs of a serious condition.

Keep OUT OF THE REACH OF CHILDREN

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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75660-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	2725.5 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	51.1 mL
WATER (UNII: 059QF0KO0R)	991.78 mL
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)	9.46 mL
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)	0.38 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	6.81 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75660-003-01	1 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020
2	NDC: 75660-003-04	1 in 1 BOX	06/01/2020
2		4 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 75660-003-06	1 in 1 BOX	06/01/2020
3		6 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 75660-003-05	5 in 1 CONTAINER; Type 0: Not a Combination Product	06/01/2020
5	NDC: 75660-003-08	0.0625 in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2020
6	NDC: 75660-003-16	0.125 in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2020
7	NDC: 75660-003-25	2.5 in 1 CONTAINER; Type 0: Not a Combination Product	06/01/2020
8	NDC: 75660-003-02	0.015625 in 1 BOTTLE, PLASTIC; 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	06/01/2020

Labeler - Solvents and Petroleum Service, Inc. (013277454)

Registrant - Solvents and Petroleum Service, Inc. (117505240)

Establishment
Name	Address	ID/FEI	Business Operations
Clean All		117505240	manufacture(75660-003) , repack(75660-003)