Label: 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 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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