FOAMING ALCOHOL HAND SANITIZER- alcohol liquid

Foaming Alcohol Hand Sanitizer by

Drug Labeling and Warnings

Foaming Alcohol Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Simoniz USA, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

​Active Ingredient

Ethyl Alcohol 62% (v/v)

​Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin after changing diapers, after assisting ill persons or before contact with a person under medical care or treatment. Recommended for repeated use.

Warnings

• For external use only. Keep out of eyes, ears or mouth.

• Discontinue use if irritation occurs

• Keep out of reach of children

FLAMMABLE.  KEEP AWAY FROM FIRE OR FLAME

Directions

• If hands are visibily soiled, wash with soap and water and dry hands.
• Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.

Other Information

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

Inactive ingredients

glycereth-2-cocoate, DEA-C8-18 Perfluroalkylethyl Phosphate, water.

Package Labeling:

INGREDIENTS AND APPEARANCE

FOAMING ALCOHOL HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63900-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63900-002-00	1000 mL in 1 BAG; Type 0: Not a Combination Product	08/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	08/07/2020

Labeler - Simoniz USA, Inc (058510272)