Label: BIOCORNEUM HC ADVANCED SCAR SUPERVISION ANTI-ITCH- hydrocortisone acetate 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 16, 2012

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  • Active ingredient


    Hydrocortisone acetate 1%

  • Purpose

    Anti-itch

  • Uses

    For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, soaps, detergents and cosmetics.

  • Warnings

    For external use only

  • Do not use

    • in or near the eyes 
    • for the treatment of diaper rash: ask a doctor
  • Stop use and ask a doctor if

    • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • ensure that affected area is clean and dry 
    • apply evenly in a very thin layer to affected area not more than 3 to 4 times daily 
    • children under 2 years of age : consult a doctor
  • Other information

    • store below 25 degree (77 degree F)
  • Inactive ingredients

    Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethyl Isosorbide, Pentylene Glycol, Propylene Glycol, Silicon Dioxide

  • Manufactured in the USA for: enaltus Suwanee, GA 30024 USA 2012 enaltus


  • bioCorneum HC Advanced Scar Supervision Anti-Itch Gel 5g (43474-000-05)


    OuterPackage


    InnerPackage


    Label

    Drug Facts

  • INGREDIENTS AND APPEARANCE
    BIOCORNEUM HC ADVANCED SCAR SUPERVISION ANTI-ITCH 
    hydrocortisone acetate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43474-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43474-000-051 in 1 CARTON
    15 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34805/10/2012
    Labeler - Enaltus Inc (038868036)
    Registrant - Enaltus Inc (038868036)
    Establishment
    NameAddressID/FEIBusiness Operations
    Formulated Solutions, LLC143266687manufacture
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