Label: WOUND GEL PROFESSIONAL- allantoin gel

  • 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 9, 2021

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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 Pro

  • INGREDIENTS AND APPEARANCE
    WOUND GEL PROFESSIONAL 
    allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71521-038
    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:71521-038-5050 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/31/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/31/2021
    Labeler - Lavior Inc (080685327)
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