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

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

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

Image of Carton

NDC 61787-188-02

ZOSTRIX®

DIABETIC

FOOT PAIN RELIEF CREAM

For Relief of Diabetic Foot Pain

 

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     
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:61787-188-02 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 10/01/2009 03/31/2016
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(61787-188)

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