Zostrix Original Strength

Dosage form: cream
Ingredients: CAPSAICIN .25mg in 1g
Labeler: Health Care Products
NDC Code: 61787-442

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

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
ZOSTRIX ORIGINAL STRENGTH 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-442
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN.25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
PEG-100 STEARATE 
WATER 
SORBITOL 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:61787-442-021 TUBE 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/FEIOperations
Process Technologies & Packaging, LLC809172885MANUFACTURE(61787-442)

Revised: 05/2014
 
Health Care Products

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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