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

NDC#46581-202-04

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

LARGE SIZE

SALONPAS PAIN RELIEVING PATCH

Topical Analgesic

4 PATCHES

5.12" X 3.31"

image of 4-patch pouch label

SALONPAS PAIN RELIEVING
camphor, menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46581-202
Route of Administration	TOPICAL, PERCUTANEOUS, TRANSDERMAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	28.4 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	131 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	144 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:46581-202-04	4 in 1 POUCH; Type 0: Not a Combination Product	05/22/1998	03/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/22/1998	03/31/2019

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

Revised: 12/2018

Document Id: 32a1785d-34fc-4c7d-9dc9-7e7c877a36d0

Set id: 56a4fd80-153a-4a05-9b88-4bf3ef06b97e

Version: 3

Effective Time: 20181213

Hisamitsu Pharmaceutical Co., Inc.