Label: SHEFFIELD ADVANCED SCAR GEL- advanced scar gel gel

  • NDC Code(s): 11527-725-07
  • Packager: Sheffield Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL

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, 2022

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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

  • 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 finalpart34710/14/2021
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797MANUFACTURE(11527-725)
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