MEDICATED HEAT- capsicum patch

Medicated Heat by

Drug Labeling and Warnings

Medicated Heat by is a Otc medication manufactured, distributed, or labeled by United Exchange Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Capsicum extract 0.025 % as Capsaicin

PURPOSE

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with:

• arthritis
• simple backache
• strains
• sprains
• bruises

WARNINGS

Warnings

• For external use only.
• Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower.
• If pregnant or breastfeeding consult a healthcare professional before use.
• Allergy Alert: if you are allergic to any ingredients of this product or chili peppers contact a doctor before use.
  

DO NOT USE

Do not use

• on wounds or damage skin
• with, or at the same time as, other external analgesic products
  

WHEN USING

When using this product

• use only as directed
• do not bandage tightly or use with a heating pad
• avoid contact with eyes and mucous membranes
  

STOP USE

Stop use and ask a doctor if

• condition worsens
• symptoms persist more than 7 days or clear up and occur again within a few days
• rash, itching or excessive skin irritation develops
  

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

adults and children under 12 years of age and older

• clean and dray affected area
• remove patch from film
• apply to affected area not more than 3 to 4 times daily for 7 days
• remove patch from the skin after at most 8 hours application

children under 12 year of age consult a doctor

STORAGE AND HANDLING

Other information

• avoid storing product in direct sunlight
• protect product from excessive moisture
  

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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)