GERMFREE HAND SANITIZER GEL BABYPOWDER FRAGRANCE- ethanol gel
BIOSTECH CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Alcohol (Ethanol)

Glycerin, Triethanolamine, Carbomer, Fragrance, Water

Antiseptic

keep out of reach of the children

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

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.

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

label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	350 mL in 500 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70812-003-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/11/2020

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

Labeler - BIOSTECH CO., LTD. (687294330)

Registrant - BIOSTECH CO., LTD. (687294330)

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