PAIN RELIEF PATCHES- lidocaine

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic
Available from:
Walgreen Company
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Temporarily relieves minor pain. ■ 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. ■ 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.
Authorization status:
OTC monograph not final
Authorization number:
0363-9116-06

PAIN RELIEF PATCHES- lidocaine

Walgreen Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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PAIN RELIEF PATCHES

Active Ingredients

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

Purpos e

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.

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

Ques tions

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

PAIN RELIEF PATCHES

lidocaine kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-9 116

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 36 3-9 116 -0 6

1 in 1 KIT

0 4/0 1/20 19

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

2 PATCH

18 g

Pa rt 2

2 PATCH

18 g

Pa rt 3

2 PATCH

18 g

Part 1 of 3

SMALL PAIN RELIEF PATCHES

lidocaine patch

Product Information

Ite m Code (Source )

NDC:0 36 3-9 117

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

9 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

Aluminum (UNII: CPD4NFA9 0 3)

Glycerin (UNII: PDC6 A3C0 OX)

Ka o lin (UNII: 24H4NWX5CO)

Methylpa ra ben (UNII: A2I8 C7HI9 T)

PO LYACRYLIC ACID ( 3 0 0 0 0 0 MW) (UNII: A8 371R0 U5J)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

Pro pylene Glyco l (UNII: 6 DC9 Q16 7V3)

Pro pylpa ra ben (UNII: Z8 IX2SC1OH)

CO PO VIDO NE K2 5-3 1 (UNII: D9 C330 MD8 B)

SO DIUM PO LYACRYLATE ( 2 50 0 0 0 0 MW) (UNII: 0 5I15JNI2J)

TARTARIC ACID (UNII: W48 8 8 I119 H)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

1 in 1 POUCH

1

9 g in 1 PATCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

Part 2 of 3

MEDIUM PAIN RELIEF PATCHES

lidocaine patch

Product Information

Ite m Code (Source )

NDC:0 36 3-9 118

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

9 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

Aluminum (UNII: CPD4NFA9 0 3)

Glycerin (UNII: PDC6 A3C0 OX)

Ka o lin (UNII: 24H4NWX5CO)

Methylpa ra ben (UNII: A2I8 C7HI9 T)

PO LYACRYLIC ACID ( 3 0 0 0 0 0 MW) (UNII: A8 371R0 U5J)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

Pro pylene Glyco l (UNII: 6 DC9 Q16 7V3)

Pro pylpa ra ben (UNII: Z8 IX2SC1OH)

CO PO VIDO NE K2 5-3 1 (UNII: D9 C330 MD8 B)

SO DIUM PO LYACRYLATE ( 2 50 0 0 0 0 MW) (UNII: 0 5I15JNI2J)

TARTARIC ACID (UNII: W48 8 8 I119 H)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

1 in 1 POUCH

1

9 g in 1 PATCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

Part 3 of 3

LARGE PAIN RELIEF PATCHES

lidocaine patch

Product Information

Ite m Code (Source )

NDC:0 36 3-9 119

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

9 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

Aluminum (UNII: CPD4NFA9 0 3)

Glycerin (UNII: PDC6 A3C0 OX)

Ka o lin (UNII: 24H4NWX5CO)

Methylpa ra ben (UNII: A2I8 C7HI9 T)

PO LYACRYLIC ACID ( 3 0 0 0 0 0 MW) (UNII: A8 371R0 U5J)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

Pro pylene Glyco l (UNII: 6 DC9 Q16 7V3)

Pro pylpa ra ben (UNII: Z8 IX2SC1OH)

CO PO VIDO NE K2 5-3 1 (UNII: D9 C330 MD8 B)

SO DIUM PO LYACRYLATE ( 2 50 0 0 0 0 MW) (UNII: 0 5I15JNI2J)

TARTARIC ACID (UNII: W48 8 8 I119 H)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

1 in 1 POUCH

1

9 g in 1 PATCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 4/0 1/20 19

Walgreen Company

Labeler -

Walgreen Company (008965063)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Fo shan Aqua Gel Bio tech Co .,Ltd.

529 128 76 3

ma nufa c ture (0 36 3-9 116 )

Revised: 3/2018

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