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Zostrix Hot and Cold Therapy System

Medically reviewed on Sep 4, 2018

Dosage form: kit
Ingredients: CAPSAICIN 0.25mg in 1g; MENTHOL 40mg in 1g
Labeler: Health Care Products
NDC Code: 61787-499

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 Facts

Active ingredient in Hot Therapy

Capsaicin 0.025%

Active ingredient in Cold Therapy

Menthol 4%

Purpose

Topical Analgesic

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

Do not apply to wounds or to damaged or irritated skin

When using Hot Therapy
  • 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.

When using Cold Therapy
  • you may experience a cooling sensation which is normal and is related to the way the product works
  • 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 heat to the treated areas immediately before or after use
  • do not tightly wrap or bandage the treated area

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 (Hot Therapy)
  • severe burning persists (Hot Therapy)
  • redness or irritation develops (Cold Therapy)

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 and gently rub in until fully absorbed
  • for optimum relief, apply 3 to 4 times daily
  • best results occur after 2 to 4 weeks of continuous use
  • wash hands thoroughly with soap and water immediately after use

Directions:For Alternating Therapy

For persons under 18 years of age, ask a doctor before using. Adults and persons 18 years of age an older: Start by applying the Cold Therapy to the affected area, then switch to the Hot Therapy and then back to the Cold Therapy and then to the Hot Therapy, using each therapy no more than 3 to 4 times per day. Best results typically occur after 2 to 4 weeks of continuous use. Wash hands thoroughly with soap and water immediately after use. See package insert for more information.

Other information
  • tamper evident: Do not use if seal at mouth of tube is missing or broken
  • store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients in Hot Therapy

Benzyl Alcohol, Cetyl Alcohol, Glyceryl Stearate, Isopropyl Myristate, PEG-100 Stearate, Purified Water, Sorbitol Solution, White Petrolatum

Inactive ingredients in Cold Therapy

Benzyl Alcohol, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Glyceryl Stearate, Isopropyl Myristate, PEG-100 Stearate, Petrolatum, Sorbitol, Water

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 #499:01 7/12

Package/Label Principal Display Panel

NEW!

NDC 61787-499-02

ZOSTRIX®

HOT & COLD

THERAPY SYSTEM

Breakthrough Pain Relief!

The Power of 2 Alternating Therapies Relieves Pain Like No Other!

Back Aches • Arthritis • Bursitis

Body Aches • Sore Muscles • Sprains

Capsaicin 0.025% Hot Therapy Cream Net Wt. 1 oz. (28.3 g)

Menthol 4.0% Cold Therapy Cream Net. Wt. 1 oz. (28.3 g)

Topical Analgesic

ZOSTRIX HOT AND COLD THERAPY SYSTEM 
capsaicin and menthol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-499
Packaging
#Item CodePackage Description
1NDC:61787-499-021 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 28.3 g
Part 21 TUBE 28.3 g
Part 1 of 2
ZOSTRIX HOT THERAPY 
capsaicin cream
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN0.25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
PEG-100 STEARATE 
WATER 
SORBITOL 
PETROLATUM 
Product Characteristics
ColorWHITE (white to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
128.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/08/2012
Part 2 of 2
ZOSTRIX COLD THERAPY 
menthol cream
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
POLYOXYL 20 CETOSTEARYL ETHER 
CETOSTEARYL ALCOHOL 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
PEG-100 STEARATE 
PETROLATUM 
SORBITOL 
WATER 
Product Characteristics
ColorWHITE (white to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
128.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/08/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/08/2012
Labeler - Health Care Products (101196749)
Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
NameAddressID/FEIOperations
San-Mar Laboratories, Inc.078718053MANUFACTURE(61787-499)

 
Health Care Products

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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