MEDICATED HEAT - capsicum  patch 
United Exchange Corporation

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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Capsicum Treatment (Medicated Heat Patch)

Active Ingredient

Capsicum extract 0.025 % as Capsaicin

Purpose

Topical Analgesic



Uses

Temporarily relieves minor pain associated with:

Warnings

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children under 12 years of age and older

children under 12 year of age consult a doctor

Other information

Inactive Ingredients

BHT, Ester gum, Isopropyl myristate, Natural rubber, Polybutene, Polyisobuthylene, Precipitated calcium carbonate, Propylene carbonate, Quinton, Sorbitan monostearate, Titanium oxide, YS resin, Zinc oxide

Image of carton label

Image of pouch label


MEDICATED HEAT 
capsicum patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55264-269
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin 0.6 mg
Product Characteristics
Color white Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55264-269-64 25 in 1 CARTON
1 3 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 05/20/2010
Labeler - United Exchange Corporation (840130579)

Revised: 5/2010
Document Id: 50f5a131-ae2a-42b5-8889-77be126f5c16
Set id: 74758792-aa41-4e89-97c9-8a801ab2dd9a
Version: 17
Effective Time: 20100517
 
United Exchange Corporation