MANAMED LIDOCAINE 4% PAIN RELIEVING GEL PATCH- lidocaine patch

ManaMed Lidocaine 4% Pain Relieving Gel Patch by

Drug Labeling and Warnings

ManaMed Lidocaine 4% Pain Relieving Gel Patch by is a Otc medication manufactured, distributed, or labeled by Manamed, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

Temporarily relieves minor pain

Warnings

For external use only

Do not use

• More than one patch on your body at a time 
• On cut, irritated or swollen skin
• On puncture wounds
• For more than one week without consulting a doctor 
• If you are allergic to any active or inactive ingredients 
• If pouch is damaged or opened

When using is product

• Use only as direacted
• Read and follow all direactions and warnings on this carton
• Do not allow contact with eyes
• Do not use at the same time as other topical analgesics
• Do not bandage tightly or apply local heat (such as heating pads)to the area of the use
• Do not microwave
• Dispose of used patch in the manner that always keeps product away from childen and 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 consult a doctor if

• Condition worsens
• Redness is present
• Irritation develops
• Symtoms persists for more than 7 days or clear up and occur 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 breastfeading, ask health professional before use.

Keep out of reach of children and pets If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Directions

Adults and children 12 years of age and over:

Clean and dry affected area.Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area.Use one patch for up to 8 hrs

Children under 12 years of age : consult a physician

Other information

Store in clean, dry place outside of direact sunlight. Protect from excessive moisture.

Inactive ingredients

Water, Glycerin, Propylene Glycol, PVP, Sodium Polyacrylate, Methylparaben, Propylparaben, Aluminum Glycinate, Kaolin, Polyacrylic Acid, Polysorbate 80, Tartaric Acid, Titanium Dioxide

Product label

INGREDIENTS AND APPEARANCE

MANAMED LIDOCAINE 4% PAIN RELIEVING GEL PATCH 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82728-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
KAOLIN (UNII: 24H4NWX5CO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82728-001-01	6 in 1 BOX	06/22/2022
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/22/2022

Labeler - Manamed, Inc. (084042331)