Label: RITE AID SCAR- allantoin 0.5% 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 June 1, 2023

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  • ACTIVE INGREDIENT

    Allantoin 0.5%

  • PURPOSE

    Skin Protectant.

  • DOSAGE & ADMINISTRATION

    Temporarily protects and helps relieve chapped or cracked skin.

  • 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 the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

    Do not use on deep or puncture wounds, animal bites, and serious burns.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Apply as needed.

  • INACTIVE INGREDIENT

    Water, Alcohol Denat., PEG-4, Propylene Glycol, Xanthan Gum, Allium Cepa (Onion) Bulk Extract, Panthenol, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Tocopherol, Glycerin, Juglans Nigra (Black Walnut) Leaf Extract, Ethylhexylglycerin, Benzyl Alcohol, Fragrance.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    RITE AID SCAR 
    allantoin 0.5% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1297
    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
    POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ONION (UNII: 492225Q21H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BLACK WALNUT (UNII: 02WM57RXZJ)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-1297-11 in 1 BOX09/15/2022
    119.8 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01609/15/2022
    Labeler - Rite Aid (014578892)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(11822-1297)
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