Label: CELLAPY DERMA MOISTURE SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69278-117-01 - Packager: GM Holdings Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 15, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
- PURPOSE
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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 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
- Uses:
- Directions
- Other information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CELLAPY DERMA MOISTURE SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69278-117 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) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Trolamine (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69278-117-01 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/01/2020 Labeler - GM Holdings Co., Ltd (688439958) Registrant - GM Holdings Co., Ltd (688439958) Establishment Name Address ID/FEI Business Operations Kukbo Science Co., Ltd. 687792812 manufacture(69278-117)