BIOGENO CARE HAND SANITIZER GEL (ETHANOL)- alcohol gel 
DERMACOS KOREA

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.

----------

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

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 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.

Directions

Other information

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

Biogeno Care Hand Sanitizer Gel 500mL

BIOGENO CARE HAND SANITIZER GEL (ETHANOL) 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77637-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77637-400-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2021
Labeler - DERMACOS KOREA (695625857)
Registrant - DERMACOS KOREA (695625857)
Establishment
NameAddressID/FEIBusiness Operations
DERMACOS KOREA695625857manufacture(77637-400)

Revised: 3/2021
Document Id: beca59e0-c0f1-3a09-e053-2a95a90a03a7
Set id: beca59e0-c0f0-3a09-e053-2a95a90a03a7
Version: 1
Effective Time: 20210330
 
DERMACOS KOREA