Label: DERMA FIRST DUO- glycerin, niacinamide, adenosine kit
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Contains inactivated NDC Code(s)
NDC Code(s): 72312-0002-1, 72312-0003-1, 72312-0004-1 - Packager: CELLALAB
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 25, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
- Derma First Mist: Spray the mist evenly on entire face after cleansing. Pat gently until it is fully absorbed. In case of sensitive skin, spray on hands and apply to face.
- Derma First Ampoule: Apply 2 or 3 drops on the face after using Derma First Mist. Gently pat on eye, mouth and nose area for better absorption.
- WARNINGS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DERMA FIRST DUO
glycerin, niacinamide, adenosine kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72312-0004 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72312-0004-1 1 in 1 CARTON; Type 0: Not a Combination Product 03/01/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, SPRAY 80 mL Part 2 1 BOTTLE, DROPPER 50 mL Part 1 of 2 DERMA FIRST MIST
glycerin, niacinamide, adenosine liquidProduct Information Item Code (Source) NDC:72312-0002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.0001 g in 100 mL Inactive Ingredients Ingredient Name Strength NIACINAMIDE (UNII: 25X51I8RD4) ADENOSINE (UNII: K72T3FS567) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72312-0002-1 80 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/01/2018 Part 2 of 2 DERMA FIRST AMPOULE
glycerin, niacinamide, anenosine liquidProduct Information Item Code (Source) NDC:72312-0003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.15 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72312-0003-1 50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/01/2018 Labeler - CELLALAB (690452262) Registrant - CELLALAB (690452262) Establishment Name Address ID/FEI Business Operations SAMSUNG MEDICOS. CO., LTD. Hyangnam Factory 689851701 manufacture(72312-0002, 72312-0003, 72312-0004) Establishment Name Address ID/FEI Business Operations CELLALAB 690452262 relabel(72312-0002, 72312-0003, 72312-0004)