GERMFREE HAND SANITIZER GEL BABYPOWDER FRAGRANCE- ethanol gel

GERMFREE HAND SANITIZER Gel babypowder fragrance by

Drug Labeling and Warnings

GERMFREE HAND SANITIZER Gel babypowder fragrance by is a Otc medication manufactured, distributed, or labeled by BIOSTECH CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol (Ethanol)

INACTIVE INGREDIENT

Glycerin, Triethanolamine, Carbomer, Fragrance, Water

PURPOSE

Antiseptic

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

do not use in or near the eyes. If contact occurs, rinse thoroughly with water.
avoid contact with broken skin.

WARNINGS

For external use only.
Flammable, keep away from heat and flame.
Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

DOSAGE & ADMINISTRATION

wet hands thoroughly with product briskly rub hands together until dry supervise children under 6 years in the use of this product

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GERMFREE HAND SANITIZER GEL BABYPOWDER FRAGRANCE 
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70812-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	350 mL  in 500 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: 70812-003-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/11/2020

Labeler - BIOSTECH CO., LTD. (687294330)

Registrant - BIOSTECH CO., LTD. (687294330)

Establishment
Name	Address	ID/FEI	Business Operations
BIOSTECH CO., LTD.		687294330	label(70812-003) , pack(70812-003) , manufacture(70812-003)