MTX TOPICAL PAIN- lidocaine hydrochloride, menthol patch
Unik Pharmaceuticals, Inc.

----------

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:

Patch2

MTX TOPICAL PAIN
lidocaine hydrochloride, menthol patch

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69889-026-15	15 in 1 BOX	09/15/2016	01/16/2017
1		8 g in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	09/15/2016	01/16/2017

Labeler - Unik Pharmaceuticals, Inc. (079835464)

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

Revised: 10/2023

Document Id: 0742f20d-a498-e96f-e063-6394a90a03a3

Set id: 3d924631-af59-42b0-e054-00144ff8d46c

Version: 5

Effective Time: 20231009

Unik Pharmaceuticals, Inc.