ZOSTRIX FOOT PAIN RELIEF- capsaicin cream
Health Care Products

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.

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Drug Facts

Active ingredient

Capsaicin 0.075%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of the muscle 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 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
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
to avoid getting cream on hands use applicator pad to apply a thin film of cream to the affected area and gently rub in until fully absorbed. Discard applicator pad after use.
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: 1-800-899-3116, 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. 188:01 3/11

Package/Label Principal Display Panel

NDC 61787-188-02

ZOSTRIX®

DIABETIC

FOOT PAIN RELIEF CREAM

For Relief of Diabetic Foot Pain

Clinically tested pain relief without a prescription
Provides powerful penetrating relief
Odorless
Greaseless

Capsaicin 0.075%

Net Wt. 2 oz. (56.6 g)

INCLUDES APPLICATOR PADS to keep hands medication free

TOPICAL ANALGESIC CREAM

ZOSTRIX FOOT PAIN RELIEF
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61787-188
Route of Administration	TOPICAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:61787-188-02	1 in 1 CARTON
1		56.6 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/01/2009	03/31/2016

Labeler - Health Care Products (101196749)

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

Name	Address	ID/FEI	Business Operations
Establishment
Process Technologies & Packaging, LLC		809172885	MANUFACTURE(61787-188)

Revised: 11/2013

Document Id: ee8d2593-6711-4733-84da-3d6edda0fd48

Set id: 19cdf2cb-1429-49a4-b74e-fa77547f6b7f

Version: 2

Effective Time: 20131108

Health Care Products