Label: HYDROCORTISONE- hydrocortisone acetate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 2, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient                            Purpose

    Hydrocortisone Acetate 1%            Antipruritic (anti-itch)

  • Uses:

    For temporary relief of;
    • minor skin irritations
    Itching and rashes due to;
    • eczema
    • insect bites
    • poison ivy
    • poison oak
    • poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry

    and for external itching of;
    •  genital
    • feminine and
    • anal itching
  • Warnings:

    For external use only

  • Do not use:

    • in the eyes
    • longer than 1 week unless directed by a physician
    • for diaper rash
    • if you have vaginal discharge
    • more than the recommended daily dosage unless directed by a doctor
    • in the rectum bu using fingers or any other mechanical device or applicator
  • Stop use and ask a physician if:

    • the condition persists or gets worse
    • symptoms clear up and occur again within a few days
    • you are pregnant or breast feeding
  • Keep out of reach of children

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

    Adults and children over 2 years of age
    • Apply evenly to affected area no more than 3 or 4 times daily.
    Children under 2 years of age
    • Do not use
    • consult a physician
    Adults
    • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
    • Gently dry, patting and blotting with bathroom tissue or soft cloth before applying
    • apply externally to the area up to 6 times daily or after each bowel movement
  • Other information:

    • Store at 20 deg - 25 deg C (68 deg - 77 deg F)
    • Avoid excessive heat and humidity
  • Inactive ingredients:

    Citric acid, Glycerin, Glycerol sterate, Methylparaben, Petrolatum, Polysorbate 80, Propylene Glycol, Propylparaben, Sodium citrate, Titanium dioxide, Water (purified)

  • Principal Display Panel

    Hydrocortisone Cream 1%

    Hydrocortisone




  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63174-224
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63174-224-0172 in 1 CASE
    128.3 g in 1 TUBE
    2NDC:63174-224-0812 in 1 CASE
    2425 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34802/02/2010
    Labeler - Choice Laboratories (650070394)
    Establishment
    NameAddressID/FEIBusiness Operations
    Choice Laboratories650070394manufacture
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