Label: HYDROCORTISONE- hydrocortisone cream cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 January 5, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Hydrocortisone Cream 1%

    Active Ingredients (in each gram)

    Hydrocortisone USP 10 mg

  • PURPOSE

    Purpose

    Antipruritic (Anti Itch)

  • INDICATIONS & USAGE

    Indications:
    For the temporary relief of itching associated with minor skin irritation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis scrapes
    For the temporary relief of external genital, feminine and anal itching
    Other uses of this product should be only under the advice and supervision of a doctor

  • WARNINGS

    Warnings:
    For external use only

    • Avoid contact with eyes
    • Do not exceed the recommended daily dosage unless directed by a doctor
    • Do no use for treatment of diaper rash
    • In case of bleeding, consult a doctor promptly

    Consult a doctor:

    • Before use if you have a vaginal discharge (for external feminine itching)
    • For external itching, do not exceed the recommended daily dosage or if bleeding occurs
    • If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days discontinue use of this product

    When using this product:

    • Do not put this product into rectum by using fingers or any mechanical device or applicator

  • STOP USE

    Do Not Use:

    • With any other Hydrocortisone product unless you have consulted a doctor
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away 1-800-222-1222

  • DOSAGE & ADMINISTRATION

    Directions:

    • For adults and children 2 years of age and older: apply externally to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: do not use, consult a doctor
    • Adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, or by patting or blotting with appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
    • Children under 12 years or age; for external anal itching, consult a doctor.
  • OTHER SAFETY INFORMATION

    Other Information:

    • Store at controlled room temperature 59* to 86*F (15* to 30*C)
    • Avoid excessive heat and humidity
    • Tamper Evident. Do not use if packet is torn, cut or opened

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Benzoic acid, chlorphenesin, citric acid, glycerin, glyceryl monostearate, methylparaben, mineral oil, petrolatum, phenoxyethanol, polysorbate 80, purified water, titanium dioxide, trisodium citrate.

  • QUESTIONS

    Questions? Call 1-800-777-4908

  • PRINCIPAL DISPLAY PANEL

    NDC 68599-1182-2
    Hydrocortisone Cream 1%
    Maximum Strength
    Effective itch and rash relief cream.
    NET WEIGHT
    0.9 g (0.03 oz)

    MFR # 118-82464

    118-82464 Each

  • PRINCIPAL DISPLAY PANEL

    NDC 68599-1182-2
    McKesson
    Hydrocortisone Cream 1%
    Maximum Strength
    NET WEIGHT
    0.9 g (0.03 oz)
    144 PACKS PER BOX
    MFR # 118-82464

    118-82464 Box

  • PRINCIPAL DISPLAY PANEL


    NDC 68599-1182-2
    McKesson
    Hydrocortisone Cream 1%
    Maximum Strength
    NET WEIGHT
    0.9 g (0.03 oz)
    144 PACKS PER BOX
    12 BOXES PER CASE
    MFR # 118-82464

    118-82464 Case

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-1182
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-1182-20.9 g in 1 PACKET; Type 0: Not a Combination Product03/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/13/201907/01/2024
    Labeler - McKesson (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004pack(68599-1182)