Label: HYDROCORTISONE cream

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

Drug Label Information

Updated October 25, 2023

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  • Drug Facts

  • Active ingredient

    Hydrocortisone 1%

    Purpose

    Anti-itch

  • Uses

    • temporary relief of external anal itching
    • temporary relief of itching associated with minor skin irritations and rashes
    • other uses of this product should be only under the advice and supervision of a doctor
  • Warnings

    For external use only.

    Do not use

    for the treatment of diaper rash. Consult a doctor.

    When using this product

    • avoid contact with the eyes
    • do not exceed the recommended daily dosage unless directed by a doctor
    • do not put into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    • bleeding occurs
    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product  unless you have consulted a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    Adults:

    • when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before application of this product.
    • adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
    • children under 12 years of age: do not use, consult a doctor
  • Other information

    store at room temperature 68° - 77° F (20° - 25° C)

  • Inactive ingredients

    aloe barbadensis leaf juice, cetyl alcohol, edetate disodium, methylparaben, mineral oil, mono- and di-glycerides, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate

  • Questions?

    Weekdays 9 AM to 4 PM EST 1-800-639-3803

  • Package Labeling:

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-230
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-230-001 in 1 BOX08/30/2022
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/30/2022
    Labeler - CVS PHARMACY, INC (062312574)
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