SALONPAS LIDOCAINE PAIN RELIEVING- lidocaine patch 
Hisamitsu Pharmaceutical Co., Inc.

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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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:

Children under 12 years of age: consult a doctor

Other information

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

IMPROVED ADHESION*1
Hisamitsu
NDC#46581-830-06
Desensitize aggravated nerves
for temporary relief of pain

Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch
APPLY FOR 8 HOURS
MAXIMUM STRENGTH*2
Numbing Relief
Unscented
6 PATCHES
3 15/16" X 5 1/2" (10cm X 14cm)
MADE IN JAPAN

image of 6-patch box label

Principal Display Panel

CUT OPEN HERE

NDC#46581-830-01

HOW TO APPLY
1 Pull apart.
2 Peel off one side of the film.
3 Place on affected area.
4 Peel off the remaining film.
5 Press patch thoroughly.

Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch

APPLY FOR 8 HOURS

MAXIMUM STRENGTH*1
Numbing Relief
Unscented

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

Child-resistant packaging.

Hisamitsu

MADE IN JAPAN

image of 1-patch pouch label

SALONPAS LIDOCAINE PAIN RELIEVING 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-830
Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE560 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46581-830-066 in 1 BOX08/01/2016
11 in 1 POUCH; Type 0: Not a Combination Product
2NDC:46581-830-022 in 1 BOX10/01/2017
21 in 1 POUCH; Type 0: Not a Combination Product
3NDC:46581-830-1515 in 1 BOX08/01/2017
31 in 1 POUCH; Type 0: Not a Combination Product
4NDC:46581-830-011 in 1 POUCH; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/2016
Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)

Revised: 8/2020
Document Id: 10797381-6e1f-40e5-b69e-c4ba8a218fb4
Set id: 4f3a438c-f378-4d2a-a95c-58e56cf1e797
Version: 6
Effective Time: 20200819
 
Hisamitsu Pharmaceutical Co., Inc.