Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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CELLAPY CLEANTECHGEL DERMA SANITIZER- alcohol gel 
GM Holdings 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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Drug Facts

ethanol (alcohol) 65.3 v/v%

glycerin, carbomer, trolamine, combination spices, water

Antiseptic

instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

instant hand antiseptic to decrease bacteria on the skin
recommended for repeated use

KEEP OUT OF REACH OF THE CHILDREN

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Supervise children in the use of this product.

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

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

Pour a small amount into hands, spread evenly and rub into the skin

label

CELLAPY CLEANTECHGEL DERMA SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69278-109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 (UNII: Z135WT9208)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69278-109-0125 mL in 1 BOTTLE; Type 0: Not a Combination Product03/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/04/2020
Labeler - GM Holdings Co., Ltd (688439958)
Registrant - GM Holdings Co., Ltd (688439958)
Establishment
NameAddressID/FEIBusiness Operations
Kukbo Science Co., Ltd.687792812manufacture(69278-109)

Revised: 3/2020
 
GM Holdings Co., Ltd


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