BIOGENO CARE HAND SANITIZER GEL (ETHANOL)- alcohol gel

Biogeno Care Hand Sanitizer Gel (Ethanol) by

Drug Labeling and Warnings

Biogeno Care Hand Sanitizer Gel (Ethanol) by is a Otc medication manufactured, distributed, or labeled by DERMACOS KOREA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer

Use

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

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Put enough product in your palm to cover hands and rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using this product.
• Not recommended for infants.

Other information

• Store at room temperature (33.8oF-86oF, 1oC-30oC) and avoid cold or dry place.
• May discolor certain fabrics or surfaces.
• Harmful to wood finishes and plastics.

Inactive ingredients

Aloe Vera Gel, Carbomer, Fragrance (Lemon), Glycerin, Green Tea Extract, Purified Water, Rosa Damascena (Rose) Flower Water, Sodium Hyaluronate, Triethanolamine.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

BIOGENO CARE HAND SANITIZER GEL (ETHANOL) 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77637-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77637-400-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2021

Labeler - DERMACOS KOREA (695625857)

Registrant - DERMACOS KOREA (695625857)

Establishment
Name	Address	ID/FEI	Business Operations
DERMACOS KOREA		695625857	manufacture(77637-400)