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MTX Topical Pain

Dosage form: patch
Ingredients: LIDOCAINE HYDROCHLORIDE 4g in 100g, MENTHOL 1g in 100g
Labeler: Unik Pharmaceuticals, Inc.
NDC Code: 69889-026

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.

MTX Topical Pain Patch

DRUG FACTS:

Active Ingredient:

Lidocaine HCl 4.00%

Menthol 1.00%

Topical Analgesic

External Analgesic

Uses:

For temporary relief of pain and itching associated with minor burns, cuts, scrapes and minor skin irritations.

Warnings:

• For external use only. Use only as directed.
• Avoid contact with eyes and mucous membranes.
• Do not apply to open wounds or damaged skin.

Do not use

• in combination with any other external analgesic products..

• Do not use with any bandage, wrap, stocking or similar device or garment.

• If symptoms persist for more than 7 days, discontinue use and consult a physician.

Keep out of reach of children.

• Children under 12 should consult physician prior to use.
• If swallowed, consult a physician
• Do not bandage tightly.

Stop use and consult physician

• if symptoms worsen or persist for more than 7 days.

If pregnant or breast feeding,

• contact physician prior to use.

Directions:

Adults and children 12-years and over: Apply to affected area.
Children under 12: consult a physician before use.
How to Apply:
• Clean and dry affected area.
• Remove patch from backing and apply directly to affected area.
• Use only one patch at a time, and maximum of four patches per day.
• Leave patch on affected area for up to 8-hours.
• Do not use patches for longer than five consecutive days.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Camellia Sinensis (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-80, Sodium Lauryl Sulfate, Triethanolamine, FD&C Blue #1, FD&C Yellow #5.

Store at room temperature.
  • Avoid direct sunlight

Package Labeling:

MTX TOPICAL PAIN 
lidocaine hydrochloride, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69889-026
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE4 g  in 100 g
MENTHOL (MENTHOL) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
WATER 
ARNICA MONTANA FLOWER 
INDIAN FRANKINCENSE 
GREEN TEA LEAF 
CARBOXYPOLYMETHYLENE 
ETHYLHEXYLGLYCERIN 
GLYCERIN 
ISOPROPYL MYRISTATE 
POLYETHYLENE GLYCOL 400 
PHENOXYETHANOL 
POLYSORBATE 80 
SODIUM LAURYL SULFATE 
TROLAMINE 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:69889-026-1515 PACKAGE in 1 BOX
18 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/15/2016
Labeler - Unik Pharmaceuticals, Inc. (079835464)
Establishment
NameAddressID/FEIOperations
Pure Source, LLC080354456manufacture(69889-026)

Revised: 02/2017
 
Unik Pharmaceuticals, Inc.

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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