WELLPATCH WARMING PAIN RELIEF- capsaicin patch

WellPatch Warming Pain Relief by

Drug Labeling and Warnings

WellPatch Warming Pain Relief by is a Otc medication manufactured, distributed, or labeled by The Mentholatum Company, Mentholatum China Pharmaceuticals Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
• avoid contact with eyes and mucous membranes
• do not apply to wounds or to damaged or very sensitive skin
• do not bandage tightly or use with a heating pad

Stop use and ask a doctor if

• condition worsens
• excessive redness, irritation, burning or discomfort of the skin develops
• symptoms persist for more than 7 days or 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 monocaprylate, 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

INGREDIENTS AND APPEARANCE

WELLPATCH WARMING PAIN RELIEF 
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-8127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	025 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)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
SORBITOL (UNII: 506T60A25R)
TALC (UNII: 7SEV7J4R1U)
TARTARIC ACID (UNII: W4888I119H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-8127-1	1 in 1 POUCH; Type 0: Not a Combination Product	12/05/2016
2	NDC: 10742-8127-2	4 in 1 POUCH; Type 0: Not a Combination Product	12/05/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/05/2016

Labeler - The Mentholatum Company (002105757)