Label: HYDROCORTISONE cream

  • Category: HUMAN OTC DRUG LABEL

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 9, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

  • Active ingredient

    Hydrocortisone 1%

    Purpose

    Anti-itch

  • Uses

    • for the temporary relief of itching associated with minor irritations and rashes
    • other uses of this product should be only under the advice and superivision of a doctor.
  • Warnings

    For external use only.

    Do not use

    for the treatment of diaper rash. Consult a doctor.

    Stop use and ask a doctor if

    • condition worsens of lasts more than 7 days, or clears up and occurs again within a few days.
    • you begin use of any other hydrocortisone product
    • bleeding occurs

    Keep out of reach of children.

    If swallowed contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: do not use.
  • Inactive ingredients

    Cetearyl alcohol, Ceteareth-20, Ethylhexylglycerin, Glycerin, Glycerol fatty acid ester, Mineral Oil, Petrolatum, Phenoxyethanol, Water

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82942-1003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82942-1003-10.9 g in 1 PACKET; Type 0: Not a Combination Product05/08/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/08/2023
    Labeler - J&A Digital Inc. (040268672)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!