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NDC 46581-0210-06 Salonpas 86.24; 166.92; 278.2 mg/1; mg/1; mg/1 Details

Salonpas 86.24; 166.92; 278.2 mg/1; mg/1; mg/1

Salonpas is a PERCUTANEOUS; TOPICAL; TRANSDERMAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Hisamitsu Pharmaceutical Co., Inc.. The primary component is CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE.

Product Information

NDC	46581-0210
Product ID	46581-210_e9abe597-0a45-4d29-bb23-8b98dbfef8c7
Associated GPIs	90809903255935
GCN Sequence Number	085502
GCN Sequence Number Description	methyl salicylate/menth/camph ADH. PATCH 10 %-6 % TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	55004
HICL Sequence Number	002581
HICL Sequence Number Description	METHYL SALICYLATE/MENTHOL/CAMPHOR
Brand/Generic	Brand
Proprietary Name	Salonpas
Proprietary Name Suffix	n/a
Non-Proprietary Name	Camphor, Menthol, Methyl salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	PERCUTANEOUS; TOPICAL; TRANSDERMAL
Active Ingredient Strength	86.24; 166.92; 278.2
Active Ingredient Units	mg/1; mg/1; mg/1
Substance Name	CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Labeler Name	Hisamitsu Pharmaceutical Co., Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 46581-0210-06 (46581021006)

Pricing Information	N/A
NDC Package Code	46581-210-06
Billing NDC	46581021006
Package	1 POUCH in 1 BOX (46581-210-06) / 6 PATCH in 1 POUCH
Marketing Start Date	2016-05-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff5 Details

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:

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

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:

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-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

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

INGREDIENTS AND APPEARANCE

SALONPAS

camphor, menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46581-210
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)	86.24 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	166.92 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	278.2 mg

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
ALUMINUM SILICATE (UNII: T1FAD4SS2M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:46581-210-06	1 in 1 BOX	05/17/2016
1		6 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/17/2016

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