Label: HYDROCORTISONE (antipruritic- anti-itch cream

  • NDC Code(s): 67777-004-01, 67777-004-02, 67777-004-03, 67777-004-04, view more
    67777-004-05, 67777-004-06, 67777-004-07, 67777-004-08
  • Packager: Dynarex Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 23, 2024

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  • Active Ingredients

    Hydrocortisone USP 1%

  • Purpose

    Antipruritic (Anti-Itch)

  • Uses

    For the 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 eyes
    • 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
    • In the rectum by 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 (do not continue to use this or any other hydrocortisone product for longer than 7 days)
    • Bleeding occurs due to anal itching

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • 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 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 by 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 15º-30ºC (59º-86ºF)
    • Avoid excessive heat
    • Tamper Evident. Do not use if seal is damaged.
  • Inactive Ingredients

    Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, White Petrolateum

  • Label

    1137 BX MASTER

  • Label

    1139 BX MASTER

  • Label 1137UB-6

    1137UB-6_BX_MASTER1137UB-6

  • Label 1137-25

    1137-25 BX_MASTER1137-25

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    antipruritic (anti-itch) cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-004
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-004-0412 in 1 CASE03/25/2021
    1NDC:67777-004-03144 in 1 BOX
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:67777-004-0172 in 1 CASE03/25/2021
    2NDC:67777-004-021 in 1 BOX
    228.4 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:67777-004-05600 in 1 CASE03/25/2021
    3NDC:67777-004-066 in 1 BOX
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:67777-004-071800 in 1 CASE03/25/2021
    4NDC:67777-004-0825 in 1 BOX
    40.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03203/25/2021
    Labeler - Dynarex Corporation (008124539)
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