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

Lidocaine Pain Relief Patch by

Drug Labeling and Warnings

Lidocaine Pain Relief Patch by is a Otc medication manufactured, distributed, or labeled by Foshan Aqua Gel Biotech Co.,Ltd.. 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, irriated or sensitive skin
• for more than one week without consulting a doctor.

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 worsens
• 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 below 25°C (77°F). Avoid direct sunilght.

Inactive Ingredients:

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

Questions or Comments?

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

Dosage and Administration

Lidocaine Pain Relief Patch contains 4% Lidocaine and 1% Menthol.

Lidocaine Pain Relief Patch

INGREDIENTS AND APPEARANCE

LIDOCAINE PAIN RELIEF PATCH 
lidocaine and menthol, unspecified form patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69159-920
Route of Administration	TOPICAL

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

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

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69159-920-05	1 in 1 CARTON	09/01/2016
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	09/01/2016

Labeler - Foshan Aqua Gel Biotech Co.,Ltd. (529128763)