Label: NANO GOLD BIO MASK PACK- allantoin patch

  • 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 April 11, 2019

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

  • ACTIVE INGREDIENT

    Active Ingredient: Allantoin 0.5%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Butylene Glycol, Glycerin, Betaine, Hamamelis Virginiana (Witch Hazel) Extract, Portulaca Oleracea Extract, Alcohol, Sodium Hyaluronate, Arbutin, Beta-Glucan, Camellia Sinensis Leaf Extract, Polyacrylamide, C13-14 Isoparaffin,Laureth-7, PEG-40 Hydrogenated Castor Oil, Cyclopentasiloxane, Psoralea Corylifolia Fruit Extract, Tocopheryl Acetate, Caprylyl Glycol, Caprylhydroxamic Acid, Triethanolamine, Sodium Chondroitin Sulfate, Squalane, Citrus Grandis (Grapefruit) Seed Extract, Centella Asiatica Extract, Hydrolyzed Collagen, Dipotassium Glycyrrhizate, Melia Azadirachta Extract, Gold, Fragrance.

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: 1. In case of having following symptoms after using this product, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: Keep out of reach of babies and children

  • INDICATIONS AND USAGE

    Indication and Usage: 1. Tighten the lid after using it. 2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3. Use it in the morning or evening after washing face.

  • DOSAGE AND ADMINISTRATION

    Dosage and Administration: Apply Nano Gold Bio Sheet Mask Pack 1 or 2 times per week. After cleansing, dry face and soothe face with toner. Gently apply the mask to fit the contours of your face. Leave on for 20-30min. Peel off the mask and massage the remaining essence over face. Before using, keep the package in the refrigerator to enjoy a refreshing, cooling mask.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    NANO GOLD BIO MASK PACK 
    allantoin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60899-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.17 mg  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60899-020-0135 mL in 1 CARTON; Type 0: Not a Combination Product09/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/01/2013
    Labeler - AMAROS CO., LTD. (690338801)
    Registrant - AMAROS CO., LTD. (690338801)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMAROS CO., LTD.690338801manufacture(60899-020)