Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

COLD AND HOT MEDICATED- menthol patch 
Mentholatum China Pharmaceutical Co. Ltd.

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

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; grasp both ends of pad firmly, pull at both ends. Stretch pad until the backing separates. Remove protective film while applying pad directly to site of pain.

Inactive ingredients

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

Package/Label Principal Display Panel

Cold and Hot Medicated Patch Menthol 5% (Large)

Package/Label Principal Display Panel

Cold and Hot Medicated Patch Menthol 5% (Small)

COLD AND HOT MEDICATED 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14785-8117
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)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
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: 14785-8117-1	5 in 1 POUCH; Type 0: Not a Combination Product	04/10/2008	08/29/2019
2	NDC: 14785-8117-2	5 in 1 POUCH; Type 0: Not a Combination Product	04/10/2008	08/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/10/2008	08/29/2019

Labeler - Mentholatum China Pharmaceutical Co. Ltd. (420786030)

Revised: 11/2010

Document Id: 6b66e548-7d3b-4fdb-8587-c84d2e0244ad

34390-5

Set id: 05dd8b85-f789-4953-b629-53bc9477bd1e

Version: 2

Effective Time: 20101108

 

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