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 America, Inc., Noven Pharmaceuticals, 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 ingredients 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, irritation, 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 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, dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, methylparaben, oleic acid, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxyde, 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#55328-100-02

Desensitize aggravated nerves

for temprary relief of pain

● Back

● Neck

● Shoulders

● Knees & Elbows

Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch

APPLY FOR UP TO 8 HOURS

MAXIMUM OTC STRENGTH

● Numbing Relief

● Unscented

2 PATCHES

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

Principal Display Panel

OTC topical analgesics in patch category*

WORLD'S BRAND NO.1

Hisamitsu

NDC#55328-100-06

Desensitize aggravated nerves

for temprary relief of pain

● Back

● Neck

● Shoulders

● Knees & Elbows

Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch

APPLY FOR UP TO 8 HOURS

MAXIMUM OTC STRENGTH

● Numbing Relief

● Unscented

6 PATCHES

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

Principal Display Panel

OTC topical analgesics in patch category*

WORLD'S BRAND NO.1

Hisamitsu

NDC#55328-100-15

Desensitize aggravated nerves

for temprary relief of pain

● Back

● Neck

● Shoulders

● Knees & Elbows

Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch

APPLY FOR UP TO 8 HOURS

MAXIMUM OTC STRENGTH

● Numbing Relief

● Unscented

15 PATCHES

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

Principal Display Panel

NOW 30 PATCHES

Hisamitsu

NDC#55328-100-30

Desensitize aggravated nerves

for temprary relief of pain

● Back

● Neck

● Shoulders

● Knees & Elbows

Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch

APPLY FOR UP TO 8 HOURS

MAXIMUM OTC STRENGTH

● Numbing Relief

● Unscented

30 PATCHES

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

Principal Display Panel

CUT OPEN HERE

Hisamitsu

NDC#55328-100-01

HOW TO APPLY

Fold sides back, pull apart to expose adhesive.

Place on affected area.

Peel off one side of the film.

Peel off the remaining film.

Press and smooth patch to secure.

Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch

APPLY FOR UP TO 8 HOURS

MAXIMUM OTC STRENGTH

● Numbing Relief

● Unscented

1 PATCH

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

Scan for HOW TO APPLY Video

INGREDIENTS AND APPEARANCE

SALONPAS LIDOCAINE PAIN RELIEVING 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55328-100
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: 55328-100-30	30 in 1 BOX	01/01/2026
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 55328-100-15	15 in 1 BOX	01/01/2026
2		1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 55328-100-06	6 in 1 BOX	01/01/2026
3		1 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 55328-100-02	2 in 1 BOX	01/01/2026
4		1 in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 55328-100-01	1 in 1 POUCH; Type 0: Not a Combination Product	01/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/01/2026

Labeler - Hisamitsu America, Inc. (191877802)

Establishment
Name	Address	ID/FEI	Business Operations
Noven Pharmaceuticals, Inc.		148585441	analysis(55328-100) , manufacture(55328-100)