ZOSTRIX ORIGINAL STRENGTH (CAPSAICIN) CREAM [HEALTH CARE PRODUCTS]

ZOSTRIX ORIGINAL STRENGTH (CAPSAICIN) CREAM [HEALTH CARE PRODUCTS]
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NDC 61787-442-02
Set ID 0eb78397-d6a1-4086-9d6c-02b45b3b9424
Category HUMAN OTC DRUG LABEL
Packager Health Care Products
Generic Name
Product Class
Product Number
Application Number PART348
  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-442
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61787-442-021 in 1 CARTON
    156.6 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/09/2006
    Labeler - Health Care Products (101196749)
    Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
    Establishment
    NameAddressID/FEIBusiness Operations
    Process Technologies & Packaging, LLC809172885MANUFACTURE(61787-442)