Label: WOUND GEL- allantoin gel

  • NDC Code(s): 71521-037-15, 71521-037-50
  • Packager: Lavior Pharma Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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  • Active Ingredient

    Allantoin 0.5%................................Skin Protectant

  • Purpose

    Skiin Protectant

  • Uses

    • helps prevent and relieve dry, chafed, chapped, or cracked skin
    • temporarily protects minor cuts, scrapes, and burns
    • helps protect from the drying effects of wind and cold weather
  • Warnings

    For external use only

  • When using this product

    • avoid contact with eyes
  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days clear up and occur again within a few days
  • Do not use

    • deep or puncture wounds
    • animal bites
    • serious burns
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply a thin layer 1 to 2 times daily, or as directed by a doctor
  • Other information

    Store at room temperature

  • Inactive Ingredients

    Water/Aqua/Eau, Glycerin, Inula Viscosa Flower/Leaf/Stem Extract, Xanthan Gum, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Propanediol, Tocopheryl Acetate, Ethylhexylglycerin, Sodium Gluconate, Citric Acid, Sodium Hyaluronate, Potassium Sorbate, Sodium Benzoate

  • Questions?

    Call toll free 1-844-474-2552 or visit www.lavior.com

  • PRINCIPAL DISPLAY PANEL

    Wound Gel

  • INGREDIENTS AND APPEARANCE
    WOUND GEL 
    allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71521-037
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DITTRICHIA VISCOSA WHOLE (UNII: 3SYW69FH88)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71521-037-5050 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/31/2021
    2NDC:71521-037-1515 g in 1 TUBE; Type 0: Not a Combination Product03/17/2022
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01603/31/2021
    Labeler - Lavior Pharma Inc (080685327)
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