ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF- capsaicin cream

Zostrix High Potency Foot Pain Relief by

Drug Labeling and Warnings

Zostrix High Potency Foot Pain Relief 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 0.075%

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

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

INGREDIENTS AND APPEARANCE

ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61787-556
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
CETYL ALCOHOL (UNII: 936JST6JCN)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61787-556-02	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	10/22/2013

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(61787-556)