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 2, 2023

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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 not finalpart34805/08/2023
    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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