Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

COLD AND HOT MEDICATED- menthol patch 
Lidl US, LLC

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 5%

Purpose

Menthol - Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints due to

• arthritis
• simple backache
• strains
• sprains
• bursitis
• tendonitis
• bruises
• cramps

Warnings

For external use only

When using this product

• use only as directed
• avoid contact with eyes or on 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

• excessive redness or irritation is present
• condition worsens
• pain persist for more than 7 days
• symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

ask a health professional before use.

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 patch to affected area as needed but not more than 4 times daily
• children under 12 years: ask a doctor
• for easy application; partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin.

Inactive ingredients

carbomer homopolymer, carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxypropyl cellulose, kaolin, partially neutralized polyacrylate, polyvinyl alcohol, purified water, sorbitol solution, tartaric acid

Package/Label Principal Display Panel

Principal Display Panel

COLD AND HOT MEDICATED 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71141-149
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	500 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CASTOR OIL (UNII: D5340Y2I9G)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
KAOLIN (UNII: 24H4NWX5CO)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TARTARIC ACID (UNII: W4888I119H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71141-149-32	1 in 1 CARTON	06/19/2017	10/31/2019
1		5 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/19/2017	10/31/2019

Labeler - Lidl US, LLC (079389709)

Revised: 11/2018

Document Id: 9506aff1-abc4-4067-a62a-e63965b20f42

34390-5

Set id: d417cb28-c9ad-414a-ae30-6b127a923f0c

Version: 2

Effective Time: 20181127

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