MTX TOPICAL PAIN- lidocaine hydrochloride, menthol patch

MTX Topical Pain by

Drug Labeling and Warnings

MTX Topical Pain by is a Otc medication manufactured, distributed, or labeled by Unik Pharmaceuticals, Inc., Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

MTX TOPICAL PAIN 
lidocaine hydrochloride, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69889-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69889-026-15	15 in 1 BOX	09/15/2016
1		8 g in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/15/2016

Labeler - Unik Pharmaceuticals, Inc. (079835464)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(69889-026)