Label: DERMA FIRST DUO- glycerin, niacinamide, adenosine kit

  • 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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Glycerin, Adenosine

  • INACTIVE INGREDIENT

    Water, Butylene Glycol, etc.

  • PURPOSE

    Skin protectant - Skin Whitening & Wrinkle Improvement

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children

  • 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

    1. Discontinue use and ask a doctor if any adverse reactions occur such as rash, swelling or irritation after use or due to direct sunlight.
    2. Do not use on damaged or broken skin.
    3. Storage and Handling Precautions

    (A)Keep out of reach of children.

    (B)Keep out of direct sunlight.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    DERMA FIRST DUO 
    glycerin, niacinamide, adenosine kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72312-0004
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72312-0004-11 in 1 CARTON; Type 0: Not a Combination Product03/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, SPRAY 80 mL
    Part 21 BOTTLE, DROPPER 50 mL
    Part 1 of 2
    DERMA FIRST MIST 
    glycerin, niacinamide, adenosine liquid
    Product Information
    Item Code (Source)NDC:72312-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.0001 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ADENOSINE (UNII: K72T3FS567)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72312-0002-180 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2018
    Part 2 of 2
    DERMA FIRST AMPOULE 
    glycerin, niacinamide, anenosine liquid
    Product Information
    Item Code (Source)NDC:72312-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72312-0003-150 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2018
    Labeler - CELLALAB (690452262)
    Registrant - CELLALAB (690452262)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAMSUNG MEDICOS. CO., LTD. Hyangnam Factory689851701manufacture(72312-0002, 72312-0003, 72312-0004)
    Establishment
    NameAddressID/FEIBusiness Operations
    CELLALAB690452262relabel(72312-0002, 72312-0003, 72312-0004)