Your browser does not support JavaScript! ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF (CAPSAICIN) CREAM [HEALTH CARE PRODUCTS]
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ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF (capsaicin) cream
[Health Care Products]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 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

ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61787-556
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN0.75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE 
WATER 
SORBITOL 
CETYL ALCOHOL 
PETROLATUM 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
BENZYL ALCOHOL 
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)

Revised: 10/2013
 
Health Care Products

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