ULTIMATE LIDOCAINE PAIN RELIEF PATCH- lidocaine and menthol, unspecified form patch

Ultimate Lidocaine Pain Relief Patch by

Drug Labeling and Warnings

Ultimate Lidocaine Pain Relief Patch by is a Otc medication manufactured, distributed, or labeled by G&N Enterprise,LLC, G & N Enterprise, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine 4%

Menthol 1%

Purpose:

Topical anesthetic

Topical anesthetic

Uses:

For the temporary relief of pain.

Warnings

• For external use only
• Avoid contact with eyes.

Do not use

• if you are allergic to any active and inactive ingredients listed in this patch
• if pouch is damaged or opened
• on raw surfaces or blistered areas, open wounds, or on damaged, cut, irritated or sensitive skin
• for more than one week without consulting a doctor.

Ask a doctor or pharmacist before use if you are

using blood thinning medications, steroids or non-steroidal anti-inflammatory drugs(NSAIDS)

When using this product

• use only as directed. Read and follow all directions and warnings on this package
• do not allow contact with eyes or mucous membranes
• do not bandage tightly or apply local heat (such as heating pads) to the area of use
• do not use at the same time as other topical analgesics
• do not reuse patch
• dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and ask a doctor if

• conditions worsen
• rash, itching or skin irritation develops
• symptoms persist for more than 7 days or clear up and occurs again within a few days
• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

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 over 12 years of age:

• clean and dry affected area
• strip off the clear protective film and place adhesive patch over affected area
• leave in place for up to 8 hours
• wash hands thoroughly after applying or removing patch.

Children under 12 years: ask a doctor before use.

Other Information

Store at room temperature-do not exceed 86° Fahrenheit, 30°Celsius.

Inactive Ingredients:

dihydroxyaluminum aminoacetate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, povidone, sodium polyacrylate, tartaric acid,titanium dioxide, water.

Questions or Comments?

Please call 1-800-290-6816 (Mon-Fri 9AM-5PM CST)

Dosage and Administration

Ultimate Lidocaine Pain Relief Patch contains 4% lidocaine and 1% menthol

Ultimate Lidocaine Pain Relief Patch

INGREDIENTS AND APPEARANCE

ULTIMATE LIDOCAINE PAIN RELIEF PATCH 
lidocaine and menthol, unspecified form patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69731-020
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
KAOLIN (UNII: 24H4NWX5CO)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69731-020-05	1 in 1 CARTON	10/01/2016
1		5 in 1 POUCH
1		9 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/01/2016

Labeler - G&N Enterprise,LLC (079758164)

Establishment
Name	Address	ID/FEI	Business Operations
G & N Enterprise, LLC		079758164	relabel(69731-020) , repack(69731-020)