SALONPAS PAIN RELIEVING LIDOCAINE 4% FLEX- lidocaine patch

Salonpas Pain Relieving LIDOCAINE 4% FLEX by

Drug Labeling and Warnings

Salonpas Pain Relieving LIDOCAINE 4% FLEX 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 1 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

• skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
• 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
• peel film from patch and apply to the skin (see illustration)
• apply 1 patch at a time to affected area, 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, mineral oil, polyisobutylene, propylene glycol, styrene-isoprene-styrene block copolymer, terpene resin

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#46581-840-07
for temporary relief of pain
PATCH CONTOURS TO YOUR BODY
Adheres as you move, bend, twist, or flex
Salonpas Pain Relieving FLEX Patch LIDOCAINE 4%
APPLY FOR UP TO 8 HOURS
MAXIMUM OTC STRENGTH
Stretchable
Thin Fabric
Strong Adhesion
7 PATCHES
2 3/4" X 3 15/16" (7cm X 10cm)
MADE IN JAPAN

INGREDIENTS AND APPEARANCE

SALONPAS PAIN RELIEVING LIDOCAINE 4% FLEX 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46581-840
Route of Administration	TOPICAL, PERCUTANEOUS, TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	42 mg

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM SILICATE (UNII: T1FAD4SS2M)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46581-840-07	7 in 1 BOX	03/01/2022
1		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 Drug	M017	03/01/2022

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