Label: HYDROCORTISONE- hydrocortisone acetate cream

  • NDC Code(s): 73598-1014-1
  • Packager: JHK Inc dba American Safety & First Aid
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 25, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydrocortisone acetate 1%

  • Purpose

    Anti-Itch Cream

  • Use

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

    • Eczema
    • Insect Bites
    • Poison Ivy, Oak or Sumac
    • Soaps, Detergents or Cosmetics
    • Jewelry
  • Warnings

    For external use only

    Do not use

    • With any other hydrocortisone product unless you have consulted a doctor
    • For the treatment of diaper rash, consult a doctor

    Stop use and ask a doctor if

    • Condition worsens
    • Symptoms persist for more than seven days
    • Symptoms clear up and occur again within a few days

    Keep out of reach of children

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

  • Directions

    • Adults and children two years and over: apply to affected area not more than three to four times daily
    • Children under two years: Do not use
  • Other Information

    • Do not use if packet is torn, cut or opened
    • Store at room temperature (do not freeze)
    • See packet for Lot Number and expiration date
  • Inactive ingredient

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

  • Questions?

    1-866-651-3660 Monday-Friday

    8:00am-5:00pm EST

  • PRINCIPAL DISPLAY PANEL - 25 Packet Carton

    Product #1014

    Hydrocortisone Cream
    USP 1%

    For the temporary relief of itching
    associated with minor skin
    irritations and rashes.

    25 - Unit Dose Packets

    PRINCIPAL DISPLAY PANEL - 25 Packet Carton
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73598-1014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE0.9 g  in 0.9 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73598-1014-125 in 1 CARTON02/02/2000
    11 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01702/02/2000
    Labeler - JHK Inc dba American Safety & First Aid (867236309)
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