ZOSTRIX HP- capsaicin cream
MEDTECH PRODUCTS INC

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Zostrix HP 61787-443

ZOSTRIX HP- capsaicin cream
Medtech Products Inc., a Prestige Consumer Healthcare company

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

Total Capsaicin 0.1%

Purpose

Topical Analgesic

Uses

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

• arthritis • simple backache • strains • 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 diminishes.

• avoid contact with eyes. Do not get it on mucous membranes, into eyes, or on contract 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, citric acid*, glyceryl stearate, isopropyl myristate, PEG-100 stearate, purified water, sorbitol solution & white petrolatum.

*May contain this ingredient to adjust pH.

Questions or Comments?

Call: 1-800-579-8327

Serious side effects associated with the use of this product may be reported to this number.

Zostrix.com

PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

ZOSTRIX®

NATURAL PAIN RELIEF

Capsaicin 0.1% Topical Analgesic

BLOCKS YOUR BODY’S PAIN MESSENGER

ODOR FREE CREAM

WARMTH FROM CHILI PEPPERS

NET WT 2.0 OZ. (57 g)

PRINCIPAL DISPLAY PANEL
MAXIMUM STRENGTH
ZOSTRIX®
NATURAL PAIN RELIEF
Capsaicin 0.1% Topical Analgesic
BLOCKS YOUR BODY’S PAIN MESSENGER
ODOR FREE CREAM
WARMTH FROM CHILI PEPPERS
NET WT 2.0 OZ. (57 g)

ZOSTRIX HP
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61787-443
Route of Administration	TOPICAL

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
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)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61787-443-02	1 in 1 CARTON	01/09/2006
1		56.6 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	01/09/2006	10/16/2023

Labeler - MEDTECH PRODUCTS INC (114707784)

Name	Address	ID/FEI	Business Operations
Establishment
Denison Pharmaceuticals, LLC		001207208	manufacture(61787-443)

Revised: 1/2025

Document Id: 1740d7fa-c4f4-44e7-9959-7f6f68fd3552

Set id: 5a9e970c-7e67-469d-b9ad-010c031ed35b

Version: 7

Effective Time: 20250117

MEDTECH PRODUCTS INC