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NDC 46581-0685-09 Salonpas Arthritis Pain 63; 210 mg/1; mg/1 Details

Salonpas Arthritis Pain 63; 210 mg/1; mg/1

Salonpas Arthritis Pain 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 MENTHOL; METHYL SALICYLATE.

Product Information

NDC	46581-0685
Product ID	46581-685_b230d296-3e49-4d61-9dbc-41d573e63f8a
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Salonpas Arthritis Pain
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol, Methyl Salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	PERCUTANEOUS; TOPICAL; TRANSDERMAL
Active Ingredient Strength	63; 210
Active Ingredient Units	mg/1; mg/1
Substance Name	MENTHOL; METHYL SALICYLATE
Labeler Name	Hisamitsu Pharmaceutical Co., Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA022029
Listing Certified Through	2023-12-31

Package

Package Images

NDC 46581-0685-09 (46581068509)

Pricing Information	N/A
NDC Package Code	46581-685-09
Billing NDC	46581068509
Package	3 POUCH in 1 BOX (46581-685-09) / 3 PATCH in 1 POUCH
Marketing Start Date	2022-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a6518167-fe32-43b2-b736-ba01ac69c12d Details

Active ingredients (in each patch)

Menthol 3%

Methyl salicylate 10% (NSAID : nonsteroidal anti-inflammatory drug)

Purpose

Topical analgesic

Uses

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:

arthritis
sprains
strains
bruises
simple backache

Warnings

For external use only

Stomach bleeding warning:

This product contains an NSAID, which may cause stomach bleeding. The chance is small but higher if you:

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others]
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Do not use

on the face or rashes
on wouds or damaged skin
if allergic to aspirin or other NSAIDs
with a heating pad
when sweating (such as from exercise or heat)
any patch from a pouch that has been open for 14 or more days
right before or after heart surgery

Ask a doctor before use if

you are allergic to topical products
the stomach bleeding warning applies to you
you are taking a diuretic
you have high blood pressure, heart disease, or kidney disease

When using this product

wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

stomach pain or upset gets worse or lasts
you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach beeding.
rash, itching or skin irritaion develops
condition worsens
symptoms last for more than 3 days
symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use methyl salicylate at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.

Directions

Adults 18 years and older:

only use one patch at a time
clean and dry affected area
remove patch from backing film and apply to skin (see illustration)
apply one patch to the affected area and leave in place for up to 8 to 12 hours
if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours
do not use more than 2 patches per day
do not use for more than 3 days in a row
the used patch should be removed from the skin when a new one is applied

Children under 18 years of age: do not use; this product has not been shown to work in children

Other information

store at 20 - 25 degrees Celsius (68-77 degrees Fahrenheit)
avoid storing product in direct sunlight
protect product from excessive moisture
some individuals may not experience pain relief until several hours after applying the patch

Inactive inredients

alicyclic saturated hydrocarbon resin, baking cloth, film, mineral oil, polyisobutylene, polyisobutylene 1,200,000, styrene-isoprene-sryrene block copolymer, synthetic aluminum silicate

Questions or comments?

Toll free 1-87-SALONPASwww.salonpas.us

Principal Display Panel

Hisamitsu

NDC#46581-685-09

LARGE

3 15/16" X 5 1/2"

for temporary relief of mild to moderate pain

Arthritis

Joint Pain

Sprains

Strains

Salonpas

Arthritis Pain Patch

APPLY FOR 8-12 HOURS

Menthol 3%

Methyl Salicylate 10%

Topical Analgesic

FDA APPROVED NON-PRESCRIPTION PAIN RELIEVING PATCH

EFFECTIVENESS CONFIRMED IN CLINICAL TRIAL

9 pathces

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

Package not child resistant.

Keep our of reach of children.

* DO NOT USE MORE THAN ONE SALONPAS PATCH AT A TIME. SEE DIRECTIONS.

INGREDIENTS AND APPEARANCE

SALONPAS ARTHRITIS PAIN

menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46581-685
Route of Administration	TOPICAL, PERCUTANEOUS, TRANSDERMAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	63 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	210 mg

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM SILICATE (UNII: T1FAD4SS2M)
MINERAL OIL (UNII: T5L8T28FGP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:46581-685-09	3 in 1 BOX	11/01/2022
1		3 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA022029	11/01/2022

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

Revised: 11/2022

Document Id: b230d296-3e49-4d61-9dbc-41d573e63f8a

Set id: a6518167-fe32-43b2-b736-ba01ac69c12d

Version: 1

Effective Time: 20221102