Label: HYDROCORTISONE ACETATE ointment

  • 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, 2017

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  • ACTIVE INGREDIENT

    Active Ingredient                            Purpose

    Hydrocortisone Acetate 1%            Antipruritic (anti-itch)

  • Warnings:

    For external use only

  • Purpose

    Hydrocortisone is 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

  • Indications and Usage

    • 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
    • For temporary relief of minor skin irritations and external itching.
  • 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.
  • Dosage and Administration

    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:

    Liquid Paraffin, White Soft Paraffin, Sorbitan Sesquioleate

  • Principal Display Panel

    Hydrocortisone

    Hydrocortisone.jpg

    Hydrocortisone

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE ACETATE 
    hydrocortisone acetate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63777-247
    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
    PARAFFIN (UNII: I9O0E3H2ZE)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63777-247-0128.4 g in 1 TUBE; Type 0: Not a Combination Product09/06/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/06/2011
    Labeler - Kinray Inc. (012574513)
    Registrant - Dynarex Corporation (008124539)
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