Label: GADADERM HYDROCORTISONE- hydrocortisone acetate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 5, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient                                   Purpose

    Hydrocortisone Acetate (0.5%)       Antiruritic (Anti-itch)

  • PURPOSE

    Purpose

    Antipruritic (Anti-itch)

  • INDICATIONS & USAGE

    Uses

    

    For temporary relief of minor skin irritations and rashes due to eczema, insect bites, poison oak, poison sumac, poison ivy, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itchin. Other uses of this product should be only under the advice and supervision of doctor.

  • WARNINGS

    Warnings: For External Use Only.

    Do not use

    • in the eyes
    • for diaper rash
    • if you have vaginal discharge
    • more than recommended dosage

    Stop use and ask a doctor if

    • the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • PREGNANCY OR BREAST FEEDING

    Ask a doctor before use if you are pregnant or breast-feeding

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children over 2 years of age: apply evenly to affected area no more than 3 to 4 times daily
    • Children under 2 years of age: Do not use. Consult a doctor

    Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Apply externally to the area up to 6 times daily or after each bowel movement. After application, discard pad. Do not flush in toilet.

  • INACTIVE INGREDIENT

    Inactive ingredients Mineral oil, propylene glycol, cety stearyl alcohol, purified water, ceteareth-6, stearyl alcohol, PEG-20 cetyl/stearyl ether, methylparaben, propylparaben

  • QUESTIONS

    GADAL Laboratories, Inc.

    Miami, Fl 33186

    www.gadallaboratories.com

  • PRINCIPAL DISPLAY PANEL

    hydrocortisone

  • INGREDIENTS AND APPEARANCE
    GADADERM HYDROCORTISONE 
    hydrocortisone acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-262
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    CETEARETH-6 (UNII: 2RJS3559D3)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53113-262-011 in 1 BOX
    142.52 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2013
    Labeler - Gadal Laboratories Inc (841305639)
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