WELLPATCH COOLING PAIN RELIEF- menthol patch

WellPatch Cooling Pain Relief by

Drug Labeling and Warnings

WellPatch Cooling 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

Menthol 5%

Purpose

Menthol - 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
• 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
• 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, ethylhexyl acrylate, glycerin, isopropyl myristate, partially neutralized polyacrylate, polyacrylic acid, polymethyl acrylate, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate starch, sorbeth-60 tetraoleate, sorbitan sesquioleate, sorbitol solution, talc, tartaric acid

Questions?

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

www.wellpatch.com

Package/Label Principal Display Panel

Principal Display Panel

INGREDIENTS AND APPEARANCE

WELLPATCH COOLING PAIN RELIEF 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-8125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - 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)
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYL ACRYLATE (UNII: WC487PR91H)
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: 10742-8125-1	1 in 1 POUCH; Type 0: Not a Combination Product	02/06/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/06/2017

Labeler - The Mentholatum Company (002105757)