Label: MAXCLINIC MIRACLINIC CONTOUR ING OBJECT- niacinamide, adenosine patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 5, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Niacinamide 2.0%, Adenosine 0.04%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Methylpropanediol, Glycerin, Glycereth-26, Panthenol, Carbomer, Trehalose, Erythritol, Hydroxyethylcellulose

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: For external use only. When using this product Keep out of eyes, Rinse with water to remove. Stop use and ask a doctor if Rash or irritation develops and lasts, Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications & usage: 1. Take out top part of MIRACLINIC ampoule dressing(no.1) and place it up aligning holes with eyes. 2. Take out lower part of ampoule dressing(no.1) place it aligning hole with lips, and over jaw line by holding it up (Adheres better when pulling it up since material is stretchy) 3. Take out lower part of ampoule dressing(no.1) place it aligning hole with lips, and over jaw line by holding it upm (Adheres better when pulling it up since material is stretchy) 4. Take out countouring object(no,2) and place from forehead, cheeks and mouth area slowing on top of ampoule dressing. 5. Adhere jaw area mask by pulling it up along facial line. 6. Gently press face with both hands supporting facial line. Supporting facial line. Adheres better if plaster is pressed till moist. 7. Take off plaster once tapping and checking plaster on cheecks is hardened after 20~30 minutes. 8. Take off the mask sheet. Remove remaining plaster from the face and finish with applying essence.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Take an adequate amount of this product. Use twice a day(morning & night).

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MAXCLINIC MIRACLINIC CONTOUR ING OBJECT 
    niacinamide, adenosine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69058-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide0.48 g  in 24 g
    Adenosine (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) Adenosine0.009 g  in 24 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Methylpropanediol (UNII: N8F53B3R4R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69058-200-021 in 1 CARTON11/01/2016
    1NDC:69058-200-0124 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2016
    Labeler - N&B LAB.Co.Ltd (690332858)
    Registrant - N&B LAB.Co.Ltd (690332858)
    Establishment
    NameAddressID/FEIBusiness Operations
    N&B LAB.Co.Ltd690332858manufacture(69058-200)