SALONPAS- 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 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

Purpose

Topical analgesic

Uses

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

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

  • use only 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
  • contisions 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

mineral oil, perfume, polyisobutylene, styrene-isoprene-styrene block copolymer, aluminum silicate, terpene resin, titanium dioxide

Questions or comments?

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

Principal Display Panel

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

Hisamitsu

NDC#46581-210-06

for temporary relief of minor aches and pains

BACKACHE
SORE SHOULDER
STIFF NECK
JOINT PAIN

Salonpas

Pain Relieving Patch

LARGE

APPLY FOR 8 HOURS

6 PATCHES

5.67" X 3.62" (14.4 X 9.2cm)

MADE IN JAPAN

image of 6-patch box label

SALONPAS 
camphor, menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-210
Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)86.24 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL166.92 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE278.2 mg
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46581-210-061 in 1 BOX05/17/2016
16 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/17/2016
Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)

Revised: 7/2018
Document Id: e9abe597-0a45-4d29-bb23-8b98dbfef8c7
Set id: 5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff5
Version: 3
Effective Time: 20180727
 
Hisamitsu Pharmaceutical Co., Inc.