ALCOHOL HAND SANITIZER- hand sanitizer gel

Alcohol hand sanitizer by

Drug Labeling and Warnings

Alcohol hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Shantou Shengmei Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 75% v/v. Purpose: Antiseptic

PURPOSE

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE

Hand sanitizer to help reduce bacteria on the skin. Recommend for repeated use.

WARNINGS

For external use only.

Flammable. Keep away from heat or flame.

WHEN USING

Keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

STOP USE

Stop use and ask a doctor if irritation develop, persisit for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children. If sallowed, get medical help right away.

DOSAGE & ADMINISTRATION

Place enough product on hands to cover hands and rub hands quickly until dry. Children under 6 years of age should be supervised when using product.

OTHER SAFETY INFORMATION

Do not store above 105F (43F). May discolor certain fabrics or surfaces.

INACTIVE INGREDIENT

Aqua, Hydrolyzed Jojoba Esters, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Aloe Barbadensis Leaf Juice Powder, Citric Acid

PRINCIPAL DISPLAY PANEL

55450-005-01 480mL

INGREDIENTS AND APPEARANCE

ALCOHOL HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55450-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55450-006-01	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/17/2020

Labeler - Shantou Shengmei Biotechnology Co., Ltd. (554528509)

Establishment
Name	Address	ID/FEI	Business Operations
Shantou Shengmei Biotechnology Co., Ltd.		554528509	manufacture(55450-006)