SIGNATURE CARE MEDICATED PAIN RELIEF PATCH- lidocaine patch

Signature Care Medicated Pain Relief Patch by

Drug Labeling and Warnings

Signature Care Medicated Pain Relief Patch by is a Otc medication manufactured, distributed, or labeled by Safeway, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine

Purpose

Topical anesthetic

Use

For temporary relief of pain

Warning

For external use

Do not use

■ More than one patch on your body at a time ■On cut, irritated or swollen skin ■On puncture wounds ■Over raw surfaces or blistered areas ■ 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 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 bandage tightly or apply local heat (such as heating pads) to the area of use ■ Do not microwave ■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.

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, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discard patch after single use ■Children under 12 years of age: consult a physician.

Other information

Other information
Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive ingredients

aluminum glycinate, carboxymethylcellulose sodium, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIGNATURE CARE MEDICATED PAIN RELIEF PATCH 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-988
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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE (UNII: FZ989GH94E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PETROLATUM (UNII: 4T6H12BN9U)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TARTARIC ACID (UNII: W4888I119H)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-988-05	5 in 1 CARTON	01/01/2025
1		9 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 21130-988-01	1 in 1 POUCH	01/01/2025
2		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 Drug	M017	01/01/2025

Labeler - Safeway, Inc. (009137209)