Hand Sanitizer by Xiamen Afgamarine Biotechnology Co., Ltd. HAND SANITIZER gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Xiamen Afgamarine Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Store below 110°F (43"C). May discolor certain fabrics or surfaces.

INACTIVE INGREDIENT

WATER

GLYCERIN
PEG-40 Hydrogenated Castor Oil

CARBOMER

TRIETHANOLAMINE
Phenoxyethanol

Parfum (Fragrance)
Aminomethy propanol

INDICATIONS & USAGE

●Place enough product on your palm to thoroughly cover your hands.
●Rub hands together biskly until dry.
●Children under 6 years of age should be supevised when using this product.

ACTIVE INGREDIENT

Alcohol

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed get medial help or contact a Poison Control Center right away.

PURPOSE

Disinfection
Sterilization
No Rinseing

WARNINGS

For external use only, Flammable. Keep product away from fire or flame.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77607-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	41.3 mL  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77607-004-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/08/2020

Labeler - Xiamen Afgamarine Biotechnology Co., Ltd. (420485152)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Afgamarine Biotechnology Co., Ltd.		420485152	manufacture(77607-004)