Label: RUGBY HYDROSKIN- hydrocortisone cream

  • 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 December 5, 2017

If you are a consumer or patient please visit this version.

  • 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)