ZOSTRIX ORIGINAL STRENGTH- capsaicin cream

Zostrix Original Strength by

Drug Labeling and Warnings

Zostrix Original Strength by is a Otc medication manufactured, distributed, or labeled by Health Care Products, Hi-Tech Pharmacal Co., Inc., Process Technologies & Packaging, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ZOSTRIX ORIGINAL STRENGTH 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61787-442
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	.25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61787-442-02	1 in 1 CARTON
1		56.6 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/09/2006

Labeler - Health Care Products (101196749)

Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)

Establishment
Name	Address	ID/FEI	Business Operations
Process Technologies & Packaging, LLC		809172885	MANUFACTURE(61787-442)