Label: ZOSTRIX HP- capsaicin cream

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 December 17, 2019

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

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-443
    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
    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:61787-443-021 in 1 CARTON01/09/2006
    156.6 g in 1 TUBE; Type 0: Not a Combination Product
    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(61787-443)