Label: HYDROCORTISONE- hydrocortisone acetate cream

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated October 14, 2019

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  • ACTIVE INGREDIENT

    Active Ingredient (in each gram): Hydrocortisone Acetate 10mg (equivalent to Hydrocortisone 1%)

  • PURPOSE

    Purpose: anti-itch cream

  • INDICATIONS & USAGE

  • WARNINGS

    Warnings: For external use only. Do not get in eyes

    Allergy alert: A severe allergic reaction to insect bites or stings may require life support measures. In such cases, immediately clal 911 or your local emergency provider.

  • DO NOT USE

    Do not use:

    • in the eyes or over large portions of the body
    • for the treatment of diaper rash
    • with any other hydrocortisone product

  • STOP USE

    Stop use and ask a doctor if:

    • condition worsens
    • condition lasts for more than 7 days
    • symptoms clear up and occur again within a few days
  • 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. 1-800-222-1222

  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children 12 years of age and over: apply topically to the area 3 to 4 times daily.

    Children under 12 years of age: do not use, ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients: Cetyl Alcohol, Citric Acid, Diazolidinyl Urea, Edetate Disodium, Glycerin, Glyceryl Monostearate, Methylparaben, Mineral Oil, Polyethylene Glycol, Propylene Glycol, Propylparaben, Purified Water, Stearic Acid, Trolamine

  • HOW SUPPLIED

    Product: 50090-4456

    NDC: 50090-4456-0 .9 g in a PACKET / 10 in a BOX, UNIT-DOSE

  • HYDROCORTISONE ACETATE

    Label Image
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-4456(NDC:50332-0042)
    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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-4456-010 in 1 BOX, UNIT-DOSE08/05/2019
    1.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/30/1990
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-4456)
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