Label: REPUERA DERMATOZYME 5% GAUZE DRESSING MASK- glycerin, allantoin liquid

  • 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 January 28, 2021

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  • Active Ingridients

    Glycerin (2%)

    Allantoin (0.1%)

  • Purpose

    skin protectant

  • Uses

    Intensivley cares the weakened skin barrier by providing sufficient hydration and nourishment.
    Gauze type of mask has less irritation when attached to the skin and it effectively delivers essence to the skin.

  • Warnings

    For external use only

    keep away from heat.

  • When using this product

    keep out of eyes.

  • Stop use and ask a doctor if

    irritation or rash occurs.

  • Keep out of reach of children.

    Keep out of reach of children.

  • Directions

    Lightly cleanse troubled face or body before attach the mask.
    Place the mask to desired afrea of the skin. Take off the mask after 10~15 minutes and tap remaining essence gently for absorption.

  • Other Information

    STORE AT ROOM TEMPERATURE

  • Inactive Ingredients

    Water,Dipropylene Glycol ,Butylene Glycol, 1,2-Hexanediol,Dendropanax Morbiferus Extract,Oryza
    Sativa (Rice) Extract,Pinus Densiflora Leaf Extract,Centella Asiatica Extract,Polygonum Cuspidatum Root Extract,Scutellaria Baicalensis Root
    Extract,Camellia Sinensis Leaf Extract,Glycyrrhiza Glabra (Licorice) Root Extract,Chamomilla Recutita (Matricaria) Flower Extract,Rosmarinus
    Officinalis (Rosemary) Leaf Extract,Caprylic/Capric Triglyceride,Hydrogenated Lecithin,
    Phytosteryl/Octyldodecyl Lauroyl Glutamate,Ceramide NP (Ceramide 3),Sodium
    Hyaluronate,Hydrolyzed Vegetable Protein,Acrylates/C10-30 Alkyl Acrylate
    Crosspolymer,Arginine,Coccinia Indica Fruit Extract,Hydroxyethylcellulose,Hydrolyzed
    Jojoba Esters,Melia Azadirachta Flower Extract,Maltodextrin ,Salvia Officinalis (Sage)
    Oil,Eucalyptus Globulus Leaf Oil, Juniperus Mexicana Oil,Sodium Citrate,Propolis Extract,Citric Acid,Copper
    Tripeptide-1,Cyanocobalamin,Polyglyceryl-10 Laurate,Disodium EDTA,Ethylhexylglycerin

  • Package Label

    81459-301-01

  • INGREDIENTS AND APPEARANCE
    REPUERA DERMATOZYME 5% GAUZE DRESSING MASK 
    glycerin, allantoin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81459-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 mg  in 100 mL
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GERANIOL (UNII: L837108USY)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ARGININE (UNII: 94ZLA3W45F)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)  
    SAGE OIL (UNII: U27K0H1H2O)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CERAMIDE NP (UNII: 4370DF050B)  
    RICE GERM (UNII: 7N2B70SFEZ)  
    PINUS DENSIFLORA LEAF (UNII: Q1Q9P50WIY)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    ROSEMARY (UNII: IJ67X351P9)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCCINIA GRANDIS LEAF (UNII: YJE89UL5PL)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    WATER (UNII: 059QF0KO0R)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
    CYANOCOBALAMIN (UNII: P6YC3EG204)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81459-301-0118 mL in 1 POUCH; Type 0: Not a Combination Product01/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/28/2021
    Labeler - ALLUV (695097760)
    Registrant - ALLUV (695097760)
    Establishment
    NameAddressID/FEIBusiness Operations
    ALLUV695097760manufacture(81459-301)
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