PAIN RELIEF PATCHES- lidocaine kit

PAIN RELIEF PATCHES by

Drug Labeling and Warnings

PAIN RELIEF PATCHES by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, Foshan Aqua Gel Biotech Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Purpose

Temporarily relieves minor pain.

Dosage and Administration

Directions Adults and children over 12 years:

■ clean and dry affected area

■ carefully remove backing from patch starting at corner

■ apply sticky side of patch to affected area

■ use one patch for up to 8 hours. Children under 12 years of age: consult a physician.

Warnings

For external use only.

Idications and Usage

Uses: Temporaily relieves minor pains.

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

■ 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.

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.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center right away.

Other Safety Information

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

Inactive Ingredients

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

Questions

TOLL-FREE

Customer Care Help Line
866-326-1313
Mon–Fri 8:30 am–4:30 pm CST

DIST. BY
WALGREEN CO.
200 WILMOT RD.
DEERFIELD, IL 60015
www.walgreens.com

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF PATCHES 
lidocaine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9116

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9116-06	1 in 1 KIT	04/01/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 PATCH	18 g
Part 2	2 PATCH	18 g
Part 3	2 PATCH	18 g

Part 1 of 3

SMALL PAIN RELIEF PATCHES 
lidocaine patch

Product Information
Item Code (Source)	NDC: 0363-9117
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Aluminum (UNII: CPD4NFA903)
Glycerin (UNII: PDC6A3C0OX)
Kaolin (UNII: 24H4NWX5CO)
Methylparaben (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 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

Part 2 of 3

MEDIUM PAIN RELIEF PATCHES 
lidocaine patch

Product Information
Item Code (Source)	NDC: 0363-9118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Aluminum (UNII: CPD4NFA903)
Glycerin (UNII: PDC6A3C0OX)
Kaolin (UNII: 24H4NWX5CO)
Methylparaben (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 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

Part 3 of 3

LARGE PAIN RELIEF PATCHES 
lidocaine patch

Product Information
Item Code (Source)	NDC: 0363-9119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Aluminum (UNII: CPD4NFA903)
Glycerin (UNII: PDC6A3C0OX)
Kaolin (UNII: 24H4NWX5CO)
Methylparaben (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/01/2019

Labeler - Walgreen Company (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co.,Ltd.		529128763	manufacture(0363-9116)