WELLPATCH WARMING 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
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

WellPatch Warming Pain Relief Patch

Principal Display Panel

Drug Facts
WELLPATCH WARMING PAIN RELIEF 
capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8127
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN025 mg
Inactive Ingredients
Ingredient NameStrength
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, UNSPECIFIED (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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8127-11 in 1 POUCH; Type 0: Not a Combination Product12/05/2016
2NDC:10742-8127-24 in 1 POUCH; Type 0: Not a Combination Product12/05/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/05/2016
Labeler - The Mentholatum Company (002105757)

Revised: 10/2021
Document Id: 3753fa2c-3af5-45c0-b81c-613ef8d21e51
Set id: ec583129-55fc-4ab1-94e5-9c900b5d95ef
Version: 2
Effective Time: 20211001
 
The Mentholatum Company