Label: ZCORT ULTRA- hydrocortisone acetate 1% 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 January 5, 2023

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  • Drug Facts Active Ingredients

    Hydrocortisone Acetate 1%

  • Purpose

    Anti-Itch

  • Uses

    Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

    • Eczema
    • psoriasis
    • poison ivy, oak, sumac
    • insect bites
    • detergents
    • jewelry
    • cosmetics
    • soaps
    • seborrheic dermatitis
    • temporarily relieves external anal and genital itching
    • other uses of this product should only be under the advice and supervision of a doctor
  • Warnings

    For external use only

  • DO NOT USE

    • for the treatment of diaper rash
    • if pregnant or nursing - consult a doctor
    • in the genital area if you have a vaginal discharge - consult a doctor
  • WHEN USING THIS PRODUCT

    • avoid contact with eyes
    • do not use more than directed unless told to do so by a doctor
    • do not put directly into the rectum by using fingers or any mechanical device or applicator
  • STOP USE AND ASK A DOCTOR

    • if condition worsens or persists for more than 7 days
    • if condition clears up and occurs again
    • if rectal bleeding occurs
    • before using any other hydrocortisone product
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    FOR ITCHING OF SKIN IRRITATION, INFLAMMATION, AND RASHES

    • adults and children 12 years of age and older apply to affected area not more than 2 to 3 times daily

    FOR EXTERNAL ANAL AND GENITAL ITCHING, ADULTS

    • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
    • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
    • apply to affected area not more than 2 to 3 times daily
    • Ages 12 to 18 years: ask a doctor
  • Other Information

    Contents filled by weight, not volume

  • Inactive Ingredients

    Aloe Barbadenis Leaf Extract, Cetearyl Alcohol, Cocos Nucifera Oil, Dehydroepiandrosterone (DHEA), Emulsifying Wax, Glycerin, Helianthus Annuus Seed Oil, Phenoxyethanol, Simmondsia Chinensis Seed Oil, Stearic Acid, Tocopherol, Water, Xanthan Gum

  • Front Display Panel and Back Card

    NEW!

    FORMULATED TO HEAL ITCH AND PROTECT COLLAGEN

    STEROID POWER

    FAST ACTING

    • Rash
    • Poison Ivy
    • Eczema
    • Insect Bites
    • Psoriasis
    • Inflammation

    UNIQUE PATENTED FORMULA

    ZCort ULTRA+ ANTI-ITCH CREAM

    NET WT 0.5 OZ (15g)

    ACTIVE INGREDIENT: HYDROCORTIZONE 1% WITH DHEA

    see zcortfront.jpg

    Front Display Panel

    ZCort Ultra+ ANTI-ITCH CREAM BACK CARD

    see zcortbackbox.jpg

    Back Card

  • INGREDIENTS AND APPEARANCE
    ZCORT  ULTRA
    hydrocortisone acetate 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81335-532
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PRASTERONE (UNII: 459AG36T1B)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    JOJOBA OIL (UNII: 724GKU717M)  
    WATER (UNII: 059QF0KO0R)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81335-532-1515 g in 1 BOX; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2021
    Labeler - RxDino, LLC (117804297)
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