Label: ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF- capsaicin cream 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/13

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

  • Active ingredient

    Capsaicin 0.075%

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  • Purpose

    Topical Analgesic

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  • Uses

    For the temporary relief of minor aches and pains of the muscles and joints associated with

    • strains
    • sprains
    • bruises
    • arthritis
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  • 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 diminishes.
    • 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
    • blistering occurs
    • difficulty breathing or swallowing occurs
    • severe burning persists

    Keep out of reach of children.

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

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  • Directions

    • for persons under 18 years of age, ask a doctor before using
    • apply a thin film of cream to the affected area 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
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  • Other information

    Store at 15°-30°C (59°-86°F).

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  • Inactive ingredients

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

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  • Questions or Comments?

    Call: 1-8666-263-9003, Mon. - Thurs. 9:00 am - 5:00 pm EST, Fri. 9:00 am - 2:30 pm EST. Serious side effects associated with the use of this product may be reported to this number.


    Rev. 556:00 8/13

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  • Package/Label Principal Display Panel

    Zostrix High Potency Foot Pain Relief Cream

    NDC 61787-556-02

    ZOSTRIX®

    HIGH POTENCY

    FOOT PAIN RELIEF CREAM

    Capsaicin 0.075% Topical Anagesic

    Provides Penetrating Relief

    • Pain relief without a prescription
    • Strong and Effective
    • Orderless
    • Greaseless

     

    Capsaicin 0.075%

    Net Wt. 2 oz. (56.6 g)

     

    TOPICAL ANALGESIC CREAM

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  • INGREDIENTS AND APPEARANCE
    ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF 
    capsaicin cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61787-556
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSAICIN (CAPSAICIN) CAPSAICIN 0.75 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ISOPROPYL MYRISTATE  
    WATER  
    SORBITOL  
    CETYL ALCOHOL  
    PETROLATUM  
    GLYCERYL MONOSTEARATE  
    PEG-100 STEARATE  
    BENZYL ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61787-556-02 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 10/22/2013
    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(61787-556)
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