ZOSTRIX HP- capsaicin cream 
MEDTECH PRODUCTS INC

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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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 TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-443
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61787-443-021 in 1 CARTON01/09/2006
156.6 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/09/2006
Labeler - MEDTECH PRODUCTS INC (114707784)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(61787-443)

Revised: 3/2022
Document Id: 6813564d-3c8c-4e02-9584-c9a78fcefe1e
Set id: 5a9e970c-7e67-469d-b9ad-010c031ed35b
Version: 6
Effective Time: 20220301
 
MEDTECH PRODUCTS INC