Label: HYDROCORTISONE (antipruritic- anti-itch cream

  • NDC Code(s): 67777-003-01, 67777-003-02
  • Packager: Dynarex Corporation
  • Category: HUMAN OTC DRUG LABEL

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 December 7, 2022

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  • Active Ingredient

    Hydrocortisone Acetate 1%

  • Purpose

    Antipruritic (Anti-Itch)

  • Uses

    For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching.

  • Warnings

    For external use only

    If pregnant or breast-feeding,

    ask a health professional before use

    Do not use

    • in the yes
    • for diaper rash
    • for external genital or feminine itching if you have a vaginal discharge
    • more than the recommended daily dosage unless directed by a doctor
    • this product in the rectumby using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, and do not use this or any other hydrocortisone product.
    • in case of bleeding when used for anal itching

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

  • Directions

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 time daily. Children under 2 years of age: consult a doctor.
    • When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: consult a doctor before using for anal itching.
  • Other Information

    • Store at room temperature
    • Avoid excessive heat
  • Inactive Ingredients

    Ceteareth-20, Cetostearyl Alcohol, Chlorocresol, Disodium EDTA, Mineral Oil, Propylene Glycol, Sodium Metabisulfite, Water, White Petrolatum

  • 1137 Label

    1137 BX MASTER

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    antipruritic (anti-itch) cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-003-011728 in 1 CASE05/03/2018
    1NDC:67777-003-02144 in 1 BOX
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/03/2018
    Labeler - Dynarex Corporation (008124539)
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