LIDOCAINE PAIN RELIEF GEL PATCH- lidocaine pain relief patch

Lidocaine Pain Relief Gel Patch by

Drug Labeling and Warnings

Lidocaine Pain Relief Gel Patch by is a Otc medication manufactured, distributed, or labeled by Dynarex. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine 4%

Puropose

Topical anesthetic

Use

For temporary relief of pain

Warnings

For external use only

Do not use

• more than 1 patch at a time
• on wounds or damaged skin
• with a heating pad
• if you are allergic to any ingredients of this product

When using this product

• use only as directed
• avoid contact with the eyes, mucous membranes or rashes
• do not bandage tightly

Stop use and ask a doctor if

• localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop
• conditions worsen
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days

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 12 years of age and over:

• clean and dry affected area
• remove film from patch and apply to the skin
• apply 1 patch at a time to affected area, not more than 3 to 4 times daily
• patch should not be applied longer than an 8 hour period

Children under 12 years of age: consult a doctor

Other Information

• Avoid storing product in direct sunlight
• Protect product from excessive moisture

Inactive Ingredients

Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Tween 80, Water

Questions?

1-888-DYNAREX

Label

INGREDIENTS AND APPEARANCE

LIDOCAINE PAIN RELIEF GEL PATCH 
lidocaine pain relief patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1000 mg

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
METHYLPARABEN (UNII: A2I8C7HI9T)
POVIDONE (UNII: FZ989GH94E)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-009-40	60 in 1 CASE	08/27/2019
1		5 in 1 BOX
1		40 mg 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	08/27/2019

Labeler - Dynarex (008124539)

Registrant - Dynarex (008124539)