Label: VANICREAM HC ANTI-ITCH- hydrocortisone cream

  • NDC Code(s): 45334-327-02, 45334-327-04
  • Packager: Pharmaceutical Specialties, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 7, 2024

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

View All Sections
  • 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, simethicone, sorbic acid, sorbitol, water

  • QUESTIONS

    Questions?

    1-800-325-8232

    www.vanicream.com

  • SPL UNCLASSIFIED SECTION

    *To learn more about our products and ingredients, visit www.vanicream.com

    facebook logo, instagram logo Official Vanicream

    PHARMACEUTICAL SPECIALTIES, INC.

    ROCHESTER, MN 55901

    1-800-325-8232

    Made in USA with select US and imported materials

    GP24H

  • 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

    Non-comedogenic ● Gluten-Free

    for Sensitive Kin

    Net Wt 2 oz (57 g)

    label

  • 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
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    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 Product02/09/201601/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/26/2016
    Labeler - Pharmaceutical Specialties, Inc. (076499557)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Specialties, Inc.076499557manufacture(45334-327) , pack(45334-327) , label(45334-327)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!