Label: SHEFFIELD ADVANCED SCAR GEL- advanced scar gel gel

  • NDC Code(s): 11527-725-07
  • Packager: Sheffield Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients 

    Allantion 0.5%

  • Purpose

    Skin Protectant 

  • Uses

    Temporarily protects and helps chapped or cracked skin

  • Warnings

    For external use only

    When using this product 

    • do not get into eyes 

    Stop Use and Ask a Doctor if

    • condition worsens
    • symptoms last for more than 7 days or clears up and occur again within a few days 

    Do Not Use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

  • Directions

    Apply as needed 

  • Other information

    • Store at room temperature 
  • Inactive ingredient

    Water (Purified), PEG 300, Allium Cepa (Onion) Bulb Extract, Xanthan Gum, Alcohol, Methylparaben, Sorbic Acid, Panthenol, Sodium Hyaluronate, Fragrance

  • Principal Display Panel –Tube

    Sheffield          NDC 11527-72-07

    Advanced Scar Gel 

    0.5% Allantoin 

    NET WT. 0.70 oz (20g)

    2720004-Sheffield_AdvancedScarGel_TUBE.jpg

    2720004-Sheffield_AdvancedScarGel_TUBE.jpg
  • Principal Display Panel – Carton

    Sheffield          NDC 11527-725-07

    Advance Scar Gel 

    Skin Protectant

    NET WT. 0.70 oz (20g)

    500077-Sheffield_AdvancedScarGel_Carton.jpg

  • INGREDIENTS AND APPEARANCE
    SHEFFIELD ADVANCED SCAR GEL 
    advanced scar gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-725
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    ONION (UNII: 492225Q21H)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Sorbic Acid (UNII: X045WJ989B)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11527-725-071 in 1 CARTON10/14/2021
    120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01610/14/2021
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797MANUFACTURE(11527-725)
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