Label: HYDROCORTISONE cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 12, 2024

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

  • DOSAGE & ADMINISTRATION

    Purpose
    Hydrocortisone USP 1% ............................................................................................................................................................................................................................................ 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 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 This product in the rectum by using fingers or any mechanical device or applicator
    Ask a doctor before use if you are using any other hydrocortisone product
    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

  • INACTIVE INGREDIENT

    nactive Ingredients Aloe Vera, Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum

  • INDICATIONS & USAGE

    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

  • KEEP OUT OF REACH OF CHILDREN

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

  • PURPOSE

    antipruritic (Anti-Itch

  • PRINCIPAL DISPLAY PANEL

    HYDRO

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84387-005
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84387-005-0128.4 g in 1 TUBE; Type 0: Not a Combination Product11/12/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/12/2024
    Labeler - ALLIED TRADE LINK LLC (029033682)
    Registrant - ALLIED TRADE LINK LLC (029033682)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOLPALDAS VISRAM AND COMPANY LIMITED858030888manufacture(84387-005)