CORTAID Maximum Strength Cream

CORTAID Maximum Strength Cream

Drug Labeling and Warnings

Drug Details

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CORTAID MAXIMUM STRENGTH- hydrocortisone cream 
Valeant Pharmaceuticals North America LLC

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.

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CORTAID Maximum Strength Cream

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

  • ▪ temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
    • ▪ eczema
    • ▪ insect bites
    • ▪ poison ivy, oak, or sumac
    • ▪ soaps
    • ▪ detergents
    • ▪ cosmetics
    • ▪ jewelry
    • ▪ seborrheic dermatitis
    • ▪ psoriasis
  • ▪ temporarily relieves external anal and genital itching
  • ▪ other uses of this product should only be under advice and supervision of a doctor

Warnings

For external use only

Do not use

  • ▪ in the genital area if you have a vaginal discharge.

Consult a doctor

  • ▪ for the treatment of diaper rash. Ask a doctor.

When using this product

  • ▪ avoid contact with eyes
  • ▪ do not use more than directed unless told to do so by a doctor
  • ▪ do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

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

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

Directions

  • for itching of skin irritation, inflammation, and rashes:
    • adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
    • children under 2 years: Do not use, ask a doctor
  • for external anal and genital itching, adults:
    • when practical, clean the affected area with mild soap and water and rinse thoroughly
    • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: Ask a doctor

Other information

  • ▪ store at 20° to 25°C (68° to 77°F)

Inactive ingredients

water, petrolatum, glycerin, mineral oil, ceteareth-6, dimethicone, VP/eicosene copolymer, phenoxyethanol, stearyl alcohol, ammonium acryloyldimethyltaurate/VP copolymer, cetyl alcohol, carbomer, edetate disodium, methylparaben, sodium citrate, ethylparaben, citric acid, propylparaben, 1sodium hydroxide


  • 1 may contain this ingredient
  • Questions/comments?

    1-800-321-4576

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    DOCTOR

    RECOMMENDED BRAND

    CORTAID®

    1% HYDROCORTISONE ANTI-ITCH CREAM

    Maximum Strength

    Itch Relief

    MAXIMUM
    STRENGTH

    CREAM

    Superior results with visibly

    healthier skin in 1 day* from:

    • Redness
    • Dryness
    • Flaking

    NET WT

    1 OZ (28 g)

    Cortaid Maximum Strength Itch Relief - 1oz Carton
    CORTAID MAXIMUM STRENGTH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0187-5521
    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
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETEARETH-6 (UNII: 2RJS3559D3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0187-5521-011 in 1 CARTON10/01/2012
    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 not finalpart34810/01/2012
    Labeler - Valeant Pharmaceuticals North America LLC (042230623)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135MANUFACTURE(0187-5521)

    Revised: 1/2017
     
    Valeant Pharmaceuticals North America LLC


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