Label: HYDROCORTISONE cream

  • NDC Code(s): 63941-312-01
  • Packager: Valu Merchandisers, Co.
  • 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 27, 2023

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  • Active Ingredient

    Hydrocortisone 1.0%

  • Purpose

    Anti-itch

  • Uses

    temporarily relieves itching associated with minor skin irritation, inflammation and rashes due to:

    • eczema
    • psoriasis
    • seborrheic dermatitis
    • poison ivy, oak, sumac
    • insect bites
    • soaps and detergents
    • cosmetics
    • jewelry
    • external feminine and anal itching

    Other uses of this product: ask a doctor

  • Warnings

    For external use only

    Do not use

    • in or near the eyes
    • by putting directly into the rectum by using fingers or any mechanical device or applicator
    • for external feminine itching if you have a vaginal discharge
    • for diaper rash: ask a doctor.

    Ask a doctor or pharmacist before use if you are

    using any other hydrocortisone product

    When using this product

    for external anal itching, do not exceed recommended daily dosage unless directed by a doctor

    Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days
    • symptoms clear up and return within a few days
    • rectal bleeding occurs

    Keep out of reach of children

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

  • Directions

    • apply to affected area not more than 3 to 4 times daily
    • for external anal itching: when practical, clean area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
    • children under 2 years, or children under 12 years with external anal itching: do not use, ask a doctor
  • Other information

    store at room temperature, protect from freezing

  • Inactive ingredients

    aloe vera, butylated hydroxytoulene, carbomer 940, cetyl alcohol, ethylparaben, glycerin, glyceryl stearate, propylene glycol, purified water, sodium lauryl sulfate, stearic acid, trolamine

  • Package label

    Best Choice Hydrocortisone Anti-Itch Cream

    image of carton

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-312
    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
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SQUALENE (UNII: 7QWM220FJH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-312-011 in 1 BOX02/29/2012
    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 finalpart34802/29/2012
    Labeler - Valu Merchandisers, Co. (868703513)
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