Label: HYDROCORTISONE lotion

  • 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 June 13, 2023

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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 not finalpart34806/12/2023
    Labeler - Mericon Industries (059943670)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mericon Industries059943670MANUFACTURE(0394-0859)
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