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Vaniply (Pharmaceutical Specialties, Inc.)

Available Formats

Dosage Form Package Information Links
OINTMENT 70 g in 1 TUBE (45334-600-02) Label Information
OINTMENT 368 g in 1 JAR (45334-600-01) Label Information
OINTMENT 5 g in 1 TUBE (45334-600-05) Label Information

Complete Vaniply Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredient

    Dimethicone, 1%


  • PURPOSE

    Purpose

    Skin Protectant


  • INDICATIONS & USAGE

    Uses

    • helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin and lips
    • helps prevent and protect from the drying effects of wind and cold weather

  • WARNINGS

    Warnings

    For external use only


  • DO NOT USE

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

  • WHEN USING

    When using this product

    • do not get into eyes

  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

  • 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

    • apply as needed

  • STORAGE AND HANDLING

    Other information

    • store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients C30-45 alkyl methicone, C30-45 olefin, hydrogenated polydecene, microcrystalline wax, polyethylene, silica dimethyl silylate


  • QUESTIONS

    Questions?

    1-800-325-8232 www.vanicream.com


  • SPL UNCLASSIFIED SECTION

    Vaniplyâ„¢ Ointment is a unique formulation that is easy-to-spread, long-lasting, and non-comedogenic. It protects and helps moisturize the skin.

    Gluten-free.

    Vanicreamâ„¢ and Vaniplyâ„¢ are trademarks or registered trademarks of Pharmaceutical Specialties, Inc. in the US or other countries.

    PHARMACEUTICAL SPECIALTIES, INC.

    ROCHESTER, MN 55901 USA


  • PRINCIPAL DISPLAY PANEL

    NDC 45334-600-02

    From the makers of Vanicreamâ„¢ Skin Cream

    Vaniplyâ„¢ Ointment

    Skin Protectant/Dry Skin Care

    DERMATOLOGIST RECOMMENDED

    Free of dyes, fragrance, masking fragrance, lanolin, parabens, formaldehyde & other preservatives

    Net Wt 2.5 oz (70 g)

    Vaniply AT16A


  • INGREDIENTS AND APPEARANCE
    VANIPLY  
    dimethicone ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:45334-600
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    C30-45 OLEFIN (UNII: 6DWD51M0O8)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    C30-45 ALKYL METHICONE (UNII: NFX970DSI2)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45334-600-02 70 g in 1 TUBE; Type 0: Not a Combination Product 02/24/2011 06/30/2019
    2 NDC:45334-600-01 368 g in 1 JAR; Type 0: Not a Combination Product 02/24/2011 09/30/2017
    3 NDC:45334-600-05 5 g in 1 TUBE; Type 0: Not a Combination Product 02/24/2011 09/30/2015
    4 NDC:45334-600-14 4 g in 1 TUBE; Type 0: Not a Combination Product 03/03/2014 04/30/2018
    5 NDC:45334-600-35 1 in 1 CARTON 02/19/2014 03/31/2019
    5 10 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 02/24/2011 06/30/2019
    Labeler - Pharmaceutical Specialties, Inc. (076499557)
    Registrant - Pharmaceutical Specialties, Inc. (076499557)
    Establishment
    Name Address ID/FEI Business Operations
    Pharmaceutical Specialties, Inc. 076499557 manufacture(45334-600)