Your browser does not support JavaScript! WELLPATCH BACKACHE PAIN RELIEF (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]
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WELLPATCH BACKACHE PAIN RELIEF (menthol) patch
[The Mentholatum Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient

Menthol, natural 5%

Purpose

Menthol, natural - 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

When using this product

  • use only as directed
  • 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 apply external heat
  • 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

Inactive ingredients

aloe barbadensis leaf juice, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, isopropyl myristate, maltodextrin, partially hydrolized polyvinyl alcohol, partially neutralized polycrylates, polyacrylic acid, polysorbate 80, purified water, sodium polyacrylate starch, sorbeth-60 tetraoleate, sorbitan sesquioleate, sorbitol solution, talc, tartaric acid, vitamin E

Questions?

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

www.wellpatch.com

Package/Label Principal Display Panel

WellPatch Backache Pain Relief Patch

Topical Analgesic with 5% Menthol

The Mentholatum Company

Orchard Park, NY 14127

Made in China

WellPatch Backache Pain Relief Patch

Package/Label Principal Display Panel

WellPatch Backache Pain Relief Pouch

WellPatch Pain Relief Patch
WELLPATCH BACKACHE PAIN RELIEF 
menthol patch
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:10742-8123
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL50 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CARBOXYMETHYLCELLULOSE SODIUM 
DIHYDROXYALUMINUM AMINOACETATE 
EDETATE DISODIUM 
GLYCERIN 
ISOPROPYL MYRISTATE 
MALTODEXTRIN 
POLYVINYL ALCOHOL 
POLYACRYLIC ACID (250000 MW) 
POLYSORBATE 80 
WATER 
SORBITAN SESQUIOLEATE 
SORBITOL 
TALC 
TARTARIC ACID 
ALPHA-TOCOPHEROL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8123-11 in 1 CARTON
14 in 1 POUCH
2NDC:10742-8123-23 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/18/2008
Labeler - The Mentholatum Company (002105757)

Revised: 5/2011
 
The Mentholatum Company

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