Label: HYDROCORTISONE 1%- hydrocortisone cream

  • NDC Code(s): 83324-047-01
  • Packager: Chain Drug Marketing Association Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 4, 2024

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

  • DRUG FACTS

  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-Itch

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

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

  • Uses

    For temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:

    ● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, sumac ● soaps

    ● detergents ● cosmetics ● jewelry ● external feminine genital and anal itching

    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 a diaper rash, consult with doctor

    For external genital itching if you have a vaginal discharge, consult doctor

  • When using this product

    • Avoid Contact with the eyes
    • Do not begin the use of any other hydrocortisone product unless you have consulted a doctor
    • For external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use and consult a doctor.
    • do not put this product into the rectum by using fingers or any medicated device or applicator.

  • Stop using this product and ask a doctor if

    • conditions worsen
    • symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
  • Directions

    Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.

    Children under 2 years of age: do not use, consult a doctor.

    For External and anal itching:

    Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.

    Children: under 12 years of age with external anal itching: consult a doctor.

  • Inactive ingredients

    Cetyl alcohol, Edetate disodium, Methylparaben, Mineral Oil, Mono-and-di-glycerides, Polysorbate 60, Propylene glycol, Propylparaben, Purified Water, Petrolatum, Sorbitan monostearate

  • Other information

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

  • SPL UNCLASSIFIED SECTION

    Distributed by: CDMA, Inc.

    Novi, MI. 48375

    www.qualitychoice.com

    Questions: 800-935-2362

    This product is not manufactured or distrubuted by Valeant Pharamceuticals North America, Inc. distributor of Cortaid.

  • PRINCIPAL DISPLAY PANEL

    99260 QC HYDROCORTISONE CREAM MAX STRENGTH 1OZ REV09 030624 CDER

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 1% 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-047
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONO- AND DICAPRYLATE (UNII: 34966F76M6)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83324-047-011 in 1 BOX03/15/2024
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/15/2024
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)