HYDROSKIN (HYDROCORTISONE) LOTION [RUGBY LABORATORIES]

HYDROSKIN (HYDROCORTISONE) LOTION [RUGBY LABORATORIES]
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NDC 0536-1079-97
Set ID 5d96dccc-5117-4a47-b0af-f2a2c09a0c8f
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories
Generic Name
Product Class
Product Number
Application Number PART348
  • Active ingredient

    Hydrocortisone 1%

  • Purpose  

    Anti-itch

  • Uses

    • for temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
    • eczema
    • psoriasis
    • poison ivy, oak, sumac
    • cosmetics
    • insect bites
    • detergents
    • jewelry
    • seborrheic dermatitis
    • soaps
    • 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

    Do not use  

    • for the treatment of diaper rash. Ask a doctor.
    • for external genital itching if you have a vaginal discharge. Ask a doctor.

    When using this product

    • avoid contact with the eyes
    • do not begin use of any other hydrocortisone product unless you have asked a doctor
    • for external anal itching 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

    Stop use and ask a doctor if

    • condition worsens
    • 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.

    Keep out of reach of children.

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

  • Directions

    shake well before use

    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:

    • Ask a doctor.

    for external anal itching:

    • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
    • children under 12 years of age with external anal itching: ask a doctor
  • Inactive ingredients

    benzyl alcohol, cetyl alcohol, glycerin, glyceryl monostearate, isopropyl palmitate, lactic acid, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, sorbitol solution 70%, stearyl alcohol, white wax.

  • Questions or comments?

    1-800-645-2158

  • Package/Label Principal Display Panel

    Rugby Laboratories

    Maximum Strength

    HydroSKIN

    hydrocortisone 1% Lotion

    HydroSKIN 1% Lotion
  • INGREDIENTS AND APPEARANCE
    HYDROSKIN 
    hydrocortisone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1079
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    LACTIC ACID, L- (UNII: F9S9FFU82N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1079-97118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/25/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/25/2015
    Labeler - Rugby Laboratories (079246066)