Label: HYDROCORTISONE cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Hydrocortisone 1.0%

  • Purpose

    Anti-itch

  • Uses:

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

    Other uses of product should be only under the advice and supervision of a doctor

  • Warnings

    For external use only

    • Do not use
    • in eyes
    • for diaper rash

    Stop use and ask a doctor if

    ▪ condition worsens or lasts for more than 7 days symptoms clear up and occur again within a few days

    ▪ you begin using other hydrocortisone products

    KEEP OUT OF REACH OF CHILDREN.

    If swallowed, contact a Poison Control Center right away.

  • Directions:

    Adults and children over 2 years of age

    • apply to affected area not more than 3 to 4 times daily
    • children under 2, consult a doctor
  • Inactive ingredients

    emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

  • Questions

    1.800.835.2263

  • PRINCIPAL DISPLAY PANEL

    Box Label Box Label

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-1133(NDC:61010-5800)
    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
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-1133-000.9 g in 1 POUCH; Type 0: Not a Combination Product05/08/2023
    2NDC:0924-1133-0110 in 1 BOX05/08/2023
    20.9 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0924-1133-0212 in 1 BOX05/08/2023
    30.9 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:0924-1133-0320 in 1 BOX05/08/2023
    40.9 g in 1 POUCH; Type 0: Not a Combination Product
    5NDC:0924-1133-0425 in 1 BOX05/08/2023
    50.9 g in 1 POUCH; Type 0: Not a Combination Product
    6NDC:0924-1133-05100 in 1 BOX05/08/2023
    60.9 g in 1 POUCH; Type 0: Not a Combination Product
    7NDC:0924-1133-06144 in 1 BOX05/08/2023
    70.9 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/08/2023
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-1133) , repack(0924-1133)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-1133) , repack(0924-1133)
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