HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Purpose

Antiseptic, Hand Sanitizer

Use

to reuce bacteria on hands, . For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame, do not use n open wounds,

S

irriation occurs, you may report side effects to 1-800-315-4467

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.
• do not use on children less than 2 months of age

Other information

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

Inactive ingredients

acrylate polymer, bittering agent, fragrance, polyethylene glycol, glycerin, hydrogen peroxide, water

Questions

1-800-315-4467, Monday through Friday 8am-5pm

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75660-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)	0.5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.35 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.18 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	30.95 mL  in 100 mL
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)	0.01 mL  in 100 mL
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)	2 mL  in 100 mL
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)	0.01 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75660-114-01	3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2020
2	NDC: 75660-114-04	4 in 1 BOX	09/01/2020
2	NDC: 75660-114-01	3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 75660-114-05	18927.05 mL in 1 CONTAINER; Type 0: Not a Combination Product	09/01/2020
4	NDC: 75660-114-06	6 in 1 BOX	09/01/2020
4	NDC: 75660-114-01	3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC: 75660-114-44	118.29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2020
6	NDC: 75660-114-08	236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2020
7	NDC: 75660-114-16	473.17 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2020
8	NDC: 75660-114-25	9463.52 mL in 1 CONTAINER; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/01/2020

Labeler - Solvents ans Petroleum Inc (013277454)

Establishment
Name	Address	ID/FEI	Business Operations
Clean All		117505240	manufacture(75660-114)