Label: HYDROCORTISONE lotion

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 27, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Uses

    For the temporary relief associated with minor skin irritations, inflammation and rashes due to:

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

    Other uses of this product should be only under the advice and supervision of a doctor.

  • Warnings

    • For external use only
    • avoid contact with the eyes

    Stop using this product 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
    • before you begin using any other hydrocortisone product

    Do not use this product and ask a doctor

    • if you have a vaginal discharge
    • before treating diaper rash
    • before using on children under 2 years of age

    For external anal itching users

    • do not exceed the recommended daily dosage unless directed by a doctor
    • in case of bleeding, consult a doctor promptly
    • do not put this product into the rectum by using fingers or any mechanical device or applicator

    Keep this and all drugs out of the reach of children

  • 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: do not use, consult a doctor

    For External Anal Itching Users

    • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
    • children under 12 years of age: consult a doctor
  • Other Information

    • store at 55 to 76F
  • Inactive Ingredients

    stearic acid, propylene glycol, lanolin alcohol in mineral oil, isopropyl in myristate, cetyl alcohol, mono- and di-glycerides, polysorbate 80, sorbitan monooleate, a scent and purified water preserved with methylparaben and propylparaben.

  • PRINCIPAL DISPLAY PANEL - 114 g Bottle Label

    0394-0859-32

    Mericon Industries, Inc.

    Hydrocortisone 1%
    Lotion

    Anti-Itch
    Poison Ivy
    Poison Oak
    Poison Sumac
    Hives • Rashes

    Net Wt. 4 oz. (114g)

    PRINCIPAL DISPLAY PANEL - 114 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0394-0859
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone1.14 g  in 114 g
    Inactive Ingredients
    Ingredient NameStrength
    stearic acid (UNII: 4ELV7Z65AP)  
    propylene glycol (UNII: 6DC9Q167V3)  
    lanolin alcohols (UNII: 884C3FA9HE)  
    mineral oil (UNII: T5L8T28FGP)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    cetyl alcohol (UNII: 936JST6JCN)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    sorbitan monooleate (UNII: 06XEA2VD56)  
    water (UNII: 059QF0KO0R)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0394-0859-3212 in 1 BOX06/12/2023
    1114 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01706/12/2023
    Labeler - Mericon Industries (059943670)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mericon Industries059943670MANUFACTURE(0394-0859)
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