SALONPAS PAIN RELIEVING- camphor, menthol, methyl salicylate 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 ingredients

Camphor 1.2%

Menthol 5.7%

Methyl salicylate 6.3%

Purpose

Topical analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Warnings

For external use only

Allergy alert:

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product

When using this product

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

Stop use and ask a doctor if

  • rash, itching or excessive skin irritation develops
  • 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 patch from film
  • apply to affected area not more than 3 to 4 times daily
  • remove patch from the skin after at most 8 hours' 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

butylated hydroxytoluene, hydrogenated rosin glycerol ester, maleated rosin glycerin ester, natural rubber latex, perfume, polybutene, polyisobutylene, silicon dioxide, starch grafted acrylate, titanium dioxide, tocopherol acetate, zinc oxide

Questions or comments?

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

Principal Display Panel

image of 20-patch box label

NDC#46581-100-20

Hisamitsu

Stiff Neck

Stiff Shoulder

Backache

Joint Pain

For temporary relief of minor aches and pains of muscles and joints associated with

  • Arthritis
  • Strains
  • Bruises
  • Sprains

SALONPAS PAIN RELIEVING PATCH

Topical Analgesic

20 PATCHES

2.56" X 1.65"

SALONPAS PAIN RELIEVING 
camphor, menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-100
Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)7.1 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL33 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE36 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46581-100-147 in 1 BOX08/01/201202/28/2019
120 in 1 POUCH; Type 0: Not a Combination Product
2NDC:46581-100-126 in 1 BOX09/01/200608/31/2015
220 in 1 POUCH; Type 0: Not a Combination Product
3NDC:46581-100-402 in 1 BOX03/01/199512/31/2018
320 in 1 POUCH; Type 0: Not a Combination Product
4NDC:46581-100-201 in 1 BOX03/01/199508/31/2018
420 in 1 POUCH; Type 0: Not a Combination Product
5NDC:46581-100-022 in 1 POUCH; Type 0: Not a Combination Product05/01/200104/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/199502/28/2019
Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)

Revised: 12/2018
Document Id: 804b617d-8a17-4e60-9278-3f52bb1a1521
Set id: 1ebe6a18-5247-4172-93ee-161416db060d
Version: 7
Effective Time: 20181213
 
Hisamitsu Pharmaceutical Co., Inc.