RUGBY HYDROSKIN (HYDROCORTISONE) CREAM [RUGBY LABORATORIES]

RUGBY HYDROSKIN (HYDROCORTISONE) CREAM [RUGBY LABORATORIES]
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NDC 0536-1069-95
Set ID 41faf3d7-c9fe-4123-9fbe-03d58adea28d
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredient                                                                       Purpose

    Hydrocortisone 1%....................................................................Anti-itch

  • PURPOSE

    Uses for the temporary relief of itching 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, feminine and anal itching.

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

  • WARNINGS

    Warnings

    • for external use only

    Do not use in the genital area if you have a vaginal discharge. Consult a doctor.
    Do not use for the treatment of diaper rash. Consult a doctor.

    • when using this product

    Avoid contact with the eyes. Do not use more than directed unless told to do so by a doctor.
    Do not put directly into the rectum by using fingers or any mechanical device or applicator

  • STOP USE

    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
    • do not begin use of any other hydrocortisone product unless you have consulted a doctor.
    • if rectal bleeding occurs.
  • DO NOT USE

    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
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.

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

    Before using any medication, read all label directions.  Keep this carton.  It contains important information.

  • INDICATIONS & USAGE

    Directions

    For itching of skin iritation, inflammation, and rashes:

    • for 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 and genital itching, adults:

    • when practical, clean the affected area with mild soap and warm water and rinse thoroughly.
    • gently dry by patting or blotting with toilet tissue or soft cloth before applying
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: consult a doctor
  • STORAGE AND HANDLING

    Other information

    • store at 20º-25ºC (68º-77ºF)
    • Lot No. and Exp. Date: see box or see crimp of tube
    • Retain carton for complete product labeling
  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Vera Gel, Butylated Hydroxytoluene, Cetanol, Liquid Paraffin, Methylparaben, Polyoxyethylene Cetylether, Propylene Glycol, Propylparaben, Purified Water, Sorbitan Monostearate, Stearyl Alcohol

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Rugby Laboratories

    31778 Enterprise Drive

    Livonia, MI 48150  USA

    www.rugbylaboratories.com


    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    HydroSKIN 1% Cream with Aloe
  • INGREDIENTS AND APPEARANCE
    RUGBY HYDROSKIN 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1069
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1069-951 in 1 CARTON07/15/2015
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/15/2015
    Labeler - Rugby Laboratories (079246066)