SALONPAS LIDOCAINE PAIN RELIEVING- lidocaine patch

Salonpas LIDOCAINE Pain Relieving by

Drug Labeling and Warnings

Salonpas LIDOCAINE Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Hisamitsu Pharmaceutical Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Uses

For temporary relief of pain

Warnings

For external use only

Do not use

• more than one patch at a time
• on wounds or damaged skin
• with a heating pad
• if you are allergic to any igredients of this product

When using this product

• use only as directed
• avoid contact with the eyes, mucous membranes or rashes
• do not bandage tightly

Stop use and ask a doctor if

• localized skin reactions occur, such as rash, itching, redness, irritaion, pain, swelling and blistering
• conditions worsen
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

Adults and children 12 years of age and over:

• clean and dry affected area
• remove film from patch and apply to the skin (see illustration)
• apply to affected are not more than 3 to 4 times daily
• remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Other information

• Avoid storing product in direct sunlight
• Protect product from excessive moisture

Inactive ingredients

aluminum silicate, dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, methylparaben, oleic acid, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions or comments?

Toll free 1-800-826-8861   www.salonpas.us

Principal Display Panel

OTC topical analgesics
in patch category*
WORLD'S BRAND NO.1

Hisamitsu

NDC#46581-830-06

Desensitize aggravated nerves
for temporary relief of pain

• Back
• Neck
• Shoulders
• Knees and Elbows

Salonpas LIDOCASINE 4% Pain Relieving Gel-Patch
APPLY FOR 8 HOURS
MAXIMUM STRENGTH*1

• Numbing Relief
• Unscented

6 PATCHES

3 15/16" X 5 1/2" (10cm X 14cm)

MADE IN JAPAN

INGREDIENTS AND APPEARANCE

SALONPAS LIDOCAINE PAIN RELIEVING 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46581-830
Route of Administration	TOPICAL, PERCUTANEOUS, TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	560 mg

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM SILICATE (UNII: T1FAD4SS2M)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
OLEIC ACID (UNII: 2UMI9U37CP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46581-830-06	6 in 1 BOX	08/01/2016
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 46581-830-02	2 in 1 BOX	10/01/2017
2		1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 46581-830-15	15 in 1 BOX	08/01/2017
3		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 not final	part348	08/01/2016

Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)