Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

WELLPATCH CAPSAICIN PAIN RELIEF- capsaicin patch 
The Mentholatum Company

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 0.025%

Purpose

Capsaicin - Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints due to

• simple backache
• arthritis
• strains
• sprains

Warnings

For external use only

• use only as directed
• do not use at least 1 hours before, or immediately after, a bath or shower
• do not get into eyes or on mucous membranes
• do not apply to wounds or to damaged or very sensitive skin
• do not bandage tightly or cover with any type of wrap except clothing
• do not use with a heating pad or with other heat sources
• do not use in combination with other external analgesic products

Stop use and ask a doctor if

• condition worsens
• excessive redness, irritation, burning or discomfort of the skin develops
• pain persists 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 and over: apply to affected area; change patch 1 to 2 times daily
• children under 12 years: ask a doctor
• FOR BEST RESULTS: apply to clean, dry skin
• tear open pouch and remove patch; if desired, cut patch to size
• grasp both ends of the patch firmly with thumbs near center
• stretch patch until the backing separates
• remove protective film while applying patch directly to site of pain
• WASH HANDS WITH SOAP AND WATER AFTER APPLYING

Inactive ingredients

carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, methylparaben, partially neutralized polyacrylate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, propylene glycol caprylate, purified water, sodium polyacrylate, sodium polyacrylate starch, sorbitol solution, talc, tartaric acid

Questions or comments?

Toll free 1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

Package/Label Principal Display Panel

Principal Display Panel

WELLPATCH CAPSAICIN PAIN RELIEF 
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-8126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	.25 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CASTOR OIL (UNII: D5340Y2I9G)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL (UNII: 532B59J990)
PROPYLENE GLYCOL CAPRYLATE (UNII: RT9P9S09QI)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TALC (UNII: 7SEV7J4R1U)
TARTARIC ACID (UNII: W4888I119H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-8126-1	1 in 1 POUCH; Type 0: Not a Combination Product	02/28/2008	04/30/2019
2	NDC: 10742-8126-2	1 in 1 CARTON	02/28/2008	04/30/2019
2		4 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/28/2008	04/30/2019

Labeler - The Mentholatum Company (002105757)

Revised: 11/2017

Document Id: da025150-6051-4471-9b7b-f5f981fd11a6

34390-5

Set id: a0243cfa-f0df-43fa-8ae4-98996a8fe581

Version: 3

Effective Time: 20171108