ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF (CAPSAICIN) CREAM [HEALTH CARE PRODUCTS]

  • Home
  • ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF (CAPSAICIN) CREAM [HEALTH CARE PRODUCTS]

ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF (CAPSAICIN) CREAM [HEALTH CARE PRODUCTS]
PDF | XML
NDC 61787-556-02
Set ID b4b89923-ab66-41be-8e27-905573afa948
Category HUMAN OTC DRUG LABEL
Packager Health Care Products
Generic Name
Product Class
Product Number
Application Number PART348
View All Sections
  • Active ingredient

    Capsaicin 0.075%

  • Purpose

    Topical Analgesic

  • Uses

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

    • strains
    • sprains
    • bruises
    • arthritis
  • 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.

  • 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
  • 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: 1-8666-263-9003, 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

  • 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

  • INGREDIENTS AND APPEARANCE
    ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-556
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.75 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61787-556-021 in 1 CARTON
    156.6 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/22/2013
    Labeler - Health Care Products (101196749)
    Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
    Establishment
    NameAddressID/FEIBusiness Operations
    Process Technologies & Packaging, LLC809172885MANUFACTURE(61787-556)
View All Sections

Related Drugs

Search DailyMed Drugs