ALCOHOL ANTIBACTERIAL GEL(NONE-RINSE)- alcohol gel

Alcohol Antibacterial Gel(None-Rinse) by

Drug Labeling and Warnings

Alcohol Antibacterial Gel(None-Rinse) by is a Otc medication manufactured, distributed, or labeled by Amicus Asia Pacific(Hubei) Healthcare Products Pte Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Store between 15- 30°C (59-86°F)

INACTIVE INGREDIENT

Purified Water USP, Triethanolamine，Carbomer，Glycerin

INDICATIONS & USAGE

Place enough product on hands to cover all surfaces. Rub hands together until dry.

ACTIVE INGREDIENT

Alcohol

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children

PURPOSE

Disinfection
Sterilization
No Rinseing

WARNINGS

1.For extermal use only.
2.Do not use in children less than 2 months of age.
3.When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
4.Stop use and ask a doctor if iritation or rash occurs. This may be signs of a serious condition.
5.Keep out of reach of children. If swallowed, get medical help or contact a Posison Control Center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALCOHOL ANTIBACTERIAL GEL(NONE-RINSE) 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54345-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	60 mL  in 80 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54345-002-01	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/03/2020

Labeler - Amicus Asia Pacific(Hubei) Healthcare Products Pte Ltd (543259254)

Establishment
Name	Address	ID/FEI	Business Operations
Amicus Asia Pacific(Hubei) Healthcare Products Pte Ltd		543259254	manufacture(54345-002)