LIDOCAINE PAIN RELIEF PATCH- lidocaine patch

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients

Lidocaine 4.0%

Purpose

Topical Anesthetic

Use

Temporaily relieves minor pain.

Warnings

For external use only.

Do not us​e ■ 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
When using this product ■ Use only as directed
■ Read and follow all directions and warnings on this carton ■ Do not allow contact with the eyes
■ Do not use at the same time as other topical analgesics ■ Do not microwave
■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use
■ Dispose of used patch in manner that always keeps product away from children 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
■ Symptoms persist 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.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 12 years of age and over: Clean and dry affected area. Carefully remove
backing from patch (see illustration). Apply sticky side of patch to affected area. Use one patch
for up to 12 hours. Discard patch after single use.
Children under 12 years of age: consult a physician.

Other Information

■ Store at room temperature ■ Avoid direct sunlight ■ Protect from excessive moisture

Inactive Ingredients

aluminum glycinate, benzyl alcohol, butylated hydroxyanisole, carboxymethylcellulose sodium,
edetate disodium, ethylhexylglycerin, glycerin, kaolin, methacrylate copolymer, oleic acid,
phenoxyethanol, polyacrylic acid, polysorbate 80, polyvinyl alcohol, propylene glycol, PVP, sodium
polyacrylate, sorbitol, tartaric acid, titanium dioxide, water

Questions or comments:

Call 1-800-540-3765

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE PAIN RELIEF PATCH 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-163
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
POLYVINYL ALCOHOL (UNII: 532B59J990)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITOL (UNII: 506T60A25R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
KAOLIN (UNII: 24H4NWX5CO)
OLEIC ACID (UNII: 2UMI9U37CP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-163-05	5 in 1 CARTON	05/01/2026
1	NDC: 57896-163-01	350 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 Drug	M017	05/01/2026

Labeler - GERI-CARE PHARMACEUTICAL CORP (611196254)

Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)