Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

WELLPATCH BACKACHE PAIN RELIEF- menthol 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

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 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

Inactive ingredients

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, isopropyl myristate, partially neutralized polyacrylate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate starch, sorbeth-60 tetraoleate, sorbitan sesquioleate, sorbitol solution, talc, tartaric acid

Questions?

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

www.wellpatch.com

Package/Label Principal Display Panel

Principal Display Panel

WELLPATCH BACKACHE PAIN RELIEF 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-8123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	50 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL (UNII: 532B59J990)
WATER (UNII: 059QF0KO0R)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
SORBITOL (UNII: 506T60A25R)
TALC (UNII: 7SEV7J4R1U)
TARTARIC ACID (UNII: W4888I119H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-8123-1	1 in 1 CARTON	01/18/2008	06/30/2019
1		4 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 10742-8123-3	1 in 1 POUCH; Type 0: Not a Combination Product	01/18/2008	06/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/18/2008	06/30/2019

Labeler - The Mentholatum Company (002105757)

Revised: 11/2017

Document Id: 99922a8a-7667-4666-99af-8a733d2ba565

34390-5

Set id: e4fc76e4-2568-4efd-ba46-ef00e64d21fc

Version: 4

Effective Time: 20171108

 

The Mentholatum Company