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

Warnings

For external use only

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

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) CAPSAICIN25 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)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
The Mentholatum Company002105757label(10742-8127)
Establishment
NameAddressID/FEIBusiness Operations
Mentholatum China Pharmaceuticals Co. Ltd.420786030manufacture(10742-8127)

Revised: 2/2023
Document Id: f4230c23-7cc4-5400-e053-2995a90a266d
Set id: ec583129-55fc-4ab1-94e5-9c900b5d95ef
Version: 3
Effective Time: 20230207
 
The Mentholatum Company