VANICREAM HC ANTI-ITCH (HYDROCORTISONE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]

VANICREAM HC ANTI-ITCH (HYDROCORTISONE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]
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NDC 45334-327-02, 45334-327-04
Set ID 28b06507-27a5-2cb1-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Pharmaceutical Specialties, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Hydrocortisone acetate 1.12%

    (equivalent to hydrocortisone 1%)

  • PURPOSE

    Purpose

    Anti-itch

  • INDICATIONS & USAGE

    Uses

    • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:

    · eczema · psoriasis · insect bites

    · detergents · jewelry · seborrheic dermatitis

    · soaps · cosmetics · poison ivy, oak, sumac

    • for the temporary relief of external genital 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

    Do not use

    • in the genital area if you have a vaginal discharge. Consult a doctor.
    • for the treatment of diaper rash. Consult a doctor.
  • WHEN USING

    When using this product

    • avoid contact with the eyes
    • do not exceed the recommended daily dosage unless directed by a doctor
    • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • rectal bleeding occurs
    • symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

    • for itching due to minor skin irritations, inflammation and rashes:
    • 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, 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
    • 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 room temperature
  • INACTIVE INGREDIENT

    Inactive ingredients ceteareth-20, cetearyl alcohol, glyceryl stearate, PEG-30 stearate, petrolatum, propanediol, purified water, simethicone, sorbic acid, sorbitol

  • QUESTIONS

    Questions?

    1-800-325-8232

    www.vanicream.com

  • SPL UNCLASSIFIED SECTION

    For information on our other products for sensitive skin, visit our website at www.vanicream.com or call 1-800-325-8232

    facebook.com/Official Vanicream

    PHARMACEUTICAL SPECIALTIES, INC.

    ROCHESTER, MN 55901

    Made in U.S.A.

  • SPL UNCLASSIFIED SECTION

    Effective relief from itching associated with minor skin irritations, inflammation, and rashes due to:

    • eczema
    • seborrheic dermatitis
    • psoriasis
    • jewelry
    • detergents
    • insect bites
    • soaps
    • cosmetics
    • poison ivy, oak, sumac

    For sensitive skin. Free of dyes, fragrance, masking fragrance, lanolin, parabens, and formaldehyde.

    non-comedogenic

    non-greasy

    easy to spread

    gluten-free

    Kid Friendly

  • SPL UNCLASSIFIED SECTION

    Vanicream is a trademark, or registered trademark, of Pharmaceutical Specialties, Inc. in the U.S. or other countries.

    © PSI 2015 All rights reserved

  • PRINCIPAL DISPLAY PANEL

    NDC 45334-327-02

    DERMATOLOGIST TESTED

    MAXIMUM STRENGTH

    VANICREAM™ HC

    1% Hydrocortisone Anti-Itch Cream

    for Sensitive Skin

    Free of dyes, fragrance, masking fragrance, lanolin, parabens, formaldehyde

    Fast relief for flare-ups due to

    • eczema
    • dermatitis
    • psoriasis

    Net Wt 2 oz (57 g)

    Vani_HC_MC17H

  • INGREDIENTS AND APPEARANCE
    VANICREAM HC ANTI-ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45334-327
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1.12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SORBIC ACID (UNII: X045WJ989B)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PEG-30 STEARATE (UNII: 1U8KB35S20)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45334-327-021 in 1 CARTON01/26/2016
    157 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:45334-327-044 g in 1 TUBE; Type 0: Not a Combination Product02/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/26/2016
    Labeler - Pharmaceutical Specialties, Inc. (076499557)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Specialties, Inc.076499557manufacture(45334-327) , pack(45334-327) , label(45334-327)

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