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Zostrix Original Strength (Health Care Products)

Available Formats

Dosage Form Package Information Links
CREAM 1 TUBE in 1 CARTON (61787-442-02) > 56.6 g in 1 TUBE Label Information

Complete Zostrix Original Strength Information

  • Active ingredient

    Capsaicin 0.025%


  • Purpose

    Topical Analgesic


  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a PoisonControlCenter immediately.


  • Uses

    • for the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and sprains

  • Warnings

    For external use only.

    Do not apply to wounds or to damaged or irritated skin.

    When using this product
    • you may experience a burning sensation which is normal and related to the way the product works. With regular use, this sensation generally disappears within several days.
    • avoid contact with eyes. Do not get it on mucous membranes, into eyes, or on contact lenses. If this occurs, rinse the affected area thoroughly with water.
    • do not apply immediately before or after activities such as bathing, swimming, sun bathing, or strenuous exercise
    • do not apply heat to the treated areas immediately before or after use
    • do not tightly wrap or bandage the treated area
    • avoid inhaling airborne material from dried residue. This can result in coughing, sneezing, tearing, throat or respiratory irritation.

    Stop use 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, discontinue use of this product and consult a doctor
    • blistering occurs
    • difficulty breathing or swallowing occurs
    • severe burning persists

  • Directions

    • for persons under 18 years of age, ask a doctor before using
    • apply a thin film of cream and gently rub in until fully absorbed
    • for optimum relief, apply 3 to 4 times daily
    • best results typically occur after 2 to 4 weeks of continuous use
    • unless treating hands, wash hands thoroughly with soap and water immediately after use
    • see package insert for more information

  • Other information

    Store at 15°-30°C (59°-86°F)


  • Inactive Ingredients

    benzyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl myristate, PEG-100 stearate, purified water, sorbitol solution & white petrolatum.


  • Questions or Comments?

    Call: 1-866-263-9003, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number.


  • Package/Label Principal Display Panel

    422_carton

  • INGREDIENTS AND APPEARANCE
    ZOSTRIX ORIGINAL STRENGTH 
    capsaicin cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61787-442
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN .25 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61787-442-02 1 in 1 CARTON
    1 56.6 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/09/2006
    Labeler - Health Care Products (101196749)
    Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
    Establishment
    Name Address ID/FEI Business Operations
    Process Technologies & Packaging, LLC 809172885 MANUFACTURE(61787-442)