Label: NEUTRACETT ALL PURPOSE- allantoin glycerin 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 November 9, 2010

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Water (Aqua), Neutracett Complex (Hyaluronic Acid, DL Panthenol), PPG-5-Ceteth-20, Ammonium Acryloyldimethyltaurate/VP Copolymer, Phenoxyethanol, Chlorphenesin, Benzoic Acid.

  • ACTIVE INGREDIENT

    Active ingredients

    Allantoin 0.5%

    Glycerin 5.0%

  • ASK DOCTOR

    Ask a doctor before use if you have: *serious burns * deep or puncture wounds * animal bites

    Questions? 800-833-4164

    www.neutracett.com Patents Pending

  • DO NOT USE

    Do not use: *if you are allergic to any of the ingredients *avoid contact with the eyes

  • STOP USE

    Stop use and ask a doctor: * if condition worsens or does not improve after 7 days * if rash or other allergic reactions occur

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: For external use only.
  • DOSAGE & ADMINISTRATION

    Directions: Gently clean area with mild cleanser. Apply gel to entire area 2 times per day or as directed. May be covered with sterile bandage. See website for more information.

  • PRINCIPAL DISPLAY PANEL

    Neutracett

    Aid 4-Healing

    Skin Recovery Treatment

    For cuts, scrapes, burns and sunburns

    All natural / won’t stain

    All Purpose Neutracett Artwork-LBL

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Uses: Helps protect the skin so your body can heal cuts, scrapes, burns and sunburns.
  • INGREDIENTS AND APPEARANCE
    NEUTRACETT  ALL PURPOSE
    allantoin glycerin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51435-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 mg  in 0.1 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51435-003-0128.3 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/28/2010
    Labeler - ADVANCED BIOMEDICS INC (023307026)
    Registrant - ADVANCED BIOMEDICS INC (023307026)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMETIC ENTERPRISES LTD017701475manufacture
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