CAPSAICIN PAIN RELIEF- capsaicin patch

Capsaicin Pain Relief by

Drug Labeling and Warnings

Capsaicin Pain Relief by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Capsicum extract 0.025% as Capsaicin

Purpose

Topical analgesic

Uses

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

• simple backache
  
• arthritis
• strains
• bruises
• sprains
  

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.

Do not use

• on wounds or damaged skin
• with a heating pad
• with, or at the same times as other external analgesic products
• if you are allergic to any ingredients of this product
  

When using this product

• use only as directed
• avoid contact with the eyes, mucous membranes or rashes
  

Stop use and ask a doctor if

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

Keep out of reach of children.

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

Directions

Adults and children 12 years of age and over:

• Clean and dry 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 hour's application

Children under 12 years of age:

• Consult a doctor
  

Other information

• Avoid storing product in direct sunlight
• Protect product from excessive moisture
  

Inactive ingredients

hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

Package label

Capsaicin Hot Patch

INGREDIENTS AND APPEARANCE

CAPSAICIN PAIN RELIEF 
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.702 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
LIQUID PETROLEUM (UNII: 6ZAE7X688J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0303-1	1 in 1 CARTON	01/23/2012
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 67510-0303-2	2 in 1 POUCH; Type 0: Not a Combination Product	05/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/23/2012

Labeler - Kareway Product, Inc. (121840057)