Home > Drugs A-Z > ZOSTRIX HP

ZOSTRIX HP (Health Care Products)

Available Formats

Dosage Form Package Information Links
CREAM 1 TUBE in 1 CARTON (61787-443-02) > 56.6 g in 1 TUBE Label Information

Complete ZOSTRIX HP Information

  • Active ingredient

    Capsaicin 0.075%


  • Purpose

    Topical Analgesic


  • Keep Out of Reach of Children


  • Uses

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

    for use in treating neuralgias, consult a physician


  • 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.

    do not get it on mucous membranes, into eyes, or on contract 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 does not improve after regular use.

    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.


  • Directions

    for persons under 18 years of age, ask a doctor before using.

    to avoid getting cream on hands use applicator pad to apply a thin film of cream to the affected area and gently rub in until fully absorbed. Discard applicator pad after use.

    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: 1-800-899-3116, 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. 443:05 8/13


  • Package/Label Principal Display Panel

    Carton

    NDC 61787-443-02

    ZOSTRIX®

    HP HIGH POTENCY

    ARTHRITIS PAIN RELIEF

    ODOR FREE CREAM

    Capsaicin 0.075% Topical Analgesic

    NET WT 2.0 OZ. (56.6g.)


  • INGREDIENTS AND APPEARANCE
    ZOSTRIX HP 
    capsaicin cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61787-443
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.75 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:61787-443-02 1 in 1 CARTON
    1 56.6 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 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(61787-443)