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Cold and Hot Medicated by Mentholatum China Pharmaceutical Co. Ltd.

Dosage form: patch
Ingredients: MENTHOL 50mg
Labeler: Mentholatum China Pharmaceutical Co. Ltd.
NDC Code: 14785-8117

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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:14785-8117
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL50 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
DIHYDROXYALUMINUM AMINOACETATE 
EDETATE DISODIUM 
GLYCERIN 
ISOPROPYL MYRISTATE 
POLYVINYL ALCOHOL 
POLYACRYLIC ACID (250000 MW) 
POLYSORBATE 80 
WATER 
SORBITAN SESQUIOLEATE 
SORBITOL 
TALC 
TARTARIC ACID 
Packaging
#Item CodePackage Description
1NDC:14785-8117-15 PATCH (PATCH) in 1 POUCH
2NDC:14785-8117-25 PATCH (PATCH) in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/10/2008
Labeler - Mentholatum China Pharmaceutical Co. Ltd. (420786030)

Revised: 11/2010
 
Mentholatum China Pharmaceutical Co. Ltd.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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