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Zostrix Hot and Cold Therapy System (Health Care Products)

Available Formats

Dosage Form Package Information Links
KIT 1 KIT in 1 CARTON (61787-499-02) * 28.3 g in 1 TUBE * 28.3 g in 1 TUBE Label Information

Complete Zostrix Hot and Cold Therapy System Information

  • Active ingredient in Hot Therapy

    Capsaicin 0.025%


  • Active ingredient in Cold Therapy

    Menthol 4%


  • Purpose

    Topical Analgesic


  • Uses

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

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains

  • Warnings

    For external use only

    Do not apply to wounds or to damaged or irritated skin

    When using Hot Therapy
    • 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.

    When using Cold Therapy
    • you may experience a cooling sensation which is normal and is related to the way the product works
    • 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 heat to the treated areas immediately before or after use
    • do not tightly wrap or bandage the treated area

    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 (Hot Therapy)
    • severe burning persists (Hot Therapy)
    • redness or irritation develops (Cold Therapy)

    Keep out of reach of children.

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


  • 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 occur after 2 to 4 weeks of continuous use
    • wash hands thoroughly with soap and water immediately after use

    Directions:For Alternating Therapy

    For persons under 18 years of age, ask a doctor before using. Adults and persons 18 years of age an older: Start by applying the Cold Therapy to the affected area, then switch to the Hot Therapy and then back to the Cold Therapy and then to the Hot Therapy, using each therapy no more than 3 to 4 times per day. Best results typically occur after 2 to 4 weeks of continuous use. Wash hands thoroughly with soap and water immediately after use. See package insert for more information.


  • Other information

    • tamper evident: Do not use if seal at mouth of tube is missing or broken
    • store at room temperature 15°-30°C (59°-86°F)

  • Inactive ingredients in Hot Therapy

    Benzyl Alcohol, Cetyl Alcohol, Glyceryl Stearate, Isopropyl Myristate, PEG-100 Stearate, Purified Water, Sorbitol Solution, White Petrolatum


  • Inactive ingredients in Cold Therapy

    Benzyl Alcohol, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Glyceryl Stearate, Isopropyl Myristate, PEG-100 Stearate, Petrolatum, Sorbitol, Water


  • Questions or Comments?

    Call: 1-800-899-3116, 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 #499:01 7/12


  • Package/Label Principal Display Panel

    Image of Carton

    NEW!

    NDC 61787-499-02

    ZOSTRIX®

    HOT & COLD

    THERAPY SYSTEM

    Breakthrough Pain Relief!

    The Power of 2 Alternating Therapies Relieves Pain Like No Other!

    Back Aches Arthritis Bursitis

    Body Aches Sore Muscles Sprains

    Capsaicin 0.025% Hot Therapy Cream Net Wt. 1 oz. (28.3 g)

    Menthol 4.0% Cold Therapy Cream Net. Wt. 1 oz. (28.3 g)

    Topical Analgesic


  • INGREDIENTS AND APPEARANCE
    ZOSTRIX HOT AND COLD THERAPY SYSTEM 
    capsaicin and menthol kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61787-499
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61787-499-02 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 TUBE 28.3 g
    Part 2 1 TUBE 28.3 g
    Part 1 of 2
    ZOSTRIX HOT THERAPY 
    capsaicin cream
    Product Information
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.25 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)  
    Product Characteristics
    Color WHITE (white to off-white) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 28.3 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 08/08/2012
    Part 2 of 2
    ZOSTRIX COLD THERAPY 
    menthol cream
    Product Information
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color WHITE (white to off-white) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 28.3 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 08/08/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 08/08/2012
    Labeler - Health Care Products (101196749)
    Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
    Establishment
    Name Address ID/FEI Business Operations
    San-Mar Laboratories, Inc. 078718053 MANUFACTURE(61787-499)