ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF- 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.

----------

Zostrix HP Foot Pain Relief 61787-556

Drug Facts

Active ingredient

Total capsaicin 0.1%

Purpose

Topical Analgesic

Uses

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

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

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

Package/Label Principal Display Panel

MAXIMUM STRENGTH

ZOSTRIX®

NATURAL FOOT PAIN RELIEF

Capsaicin 0.1% Topical Anagesic

BLOCKS YOUR BODY’S PAIN MESSENGER

 Net Wt. 2 oz. (57 g)

MAXIMUM STRENGTH
ZOSTRIX®
NATURAL FOOT PAIN RELIEF
Capsaicin 0.1% Topical Anagesic
BLOCKS YOUR BODY’S PAIN MESSENGER
• ODOR FREE CREAM
• WARMTH FROM CHILI PEPPERS
 Net Wt. 2 oz. (57 g)

ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-556
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61787-556-021 in 1 CARTON10/22/2013
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 finalpart34810/22/2013
Labeler - MEDTECH PRODUCTS INC (114707784)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(61787-556)

Revised: 3/2022
Document Id: 29c8c84e-3b9a-40aa-88ca-d024bf2d2c1a
Set id: b4b89923-ab66-41be-8e27-905573afa948
Version: 3
Effective Time: 20220303
 
MEDTECH PRODUCTS INC