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NDC 46581-0675-09 Salonpas Pain Relief 63; 210 mg/1; mg/1 Details

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

Salonpas Pain Relief 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	46581-0675
Product ID	46581-675_f74235b4-c91a-49d3-a02b-891a5ba2e068
Associated GPIs	90809902605920
GCN Sequence Number	064937
GCN Sequence Number Description	methyl salicylate/menthol ADH. PATCH 10 %-3 % TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	18333
HICL Sequence Number	002583
HICL Sequence Number Description	METHYL SALICYLATE/MENTHOL
Brand/Generic	Brand
Proprietary Name	Salonpas Pain Relief
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	2024-12-31

Package

Package Images

NDC 46581-0675-09 (46581067509)

Pricing Information	N/A
NDC Package Code	46581-675-09
Billing NDC	46581067509
Package	3 POUCH in 1 BOX (46581-675-09) / 3 PATCH in 1 POUCH
Marketing Start Date	2018-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL acd7ba91-221a-485a-ad1f-dd41ed155656 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:

strains
sprains
simple backache
arthritis
bruises

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-styrene block copolymer, synthetic aluminum silicate

Questions or comments?

Toll free 1-87-SALONPASwww.salonpas.us

Principal Display Panel

LARGE

3 15/16" X 5 1/2"

Hisamitsu

NDC#46581-675-09

for temporary relief of mild to moderate pain

Backache

Sore Muscle

Sprains

Bruises

Salonpas

Pain Relief 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 LARGE PATCHES

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

Package not child resistant.

Keep out of reach of children.

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

Principal Display Panel

CUT OPEN HERE

NDC#46581-675-01

HOW TO APPLY

1 Peel the center film.

2 Place on affected area.

3 Slide a film.

4 Slide the other film.

Salonpas

Pain Relief 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

1 LARGE PATCH

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

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

Hisamitsu

Package not child resistant.

Keep out of reach of children.

Manufactured by

Hisamitsu Pharmaceutical Co., Inc.

408, Tashirodaikan-machi, Tosu, Saga, Japan

Distributed by

Hisamitsu America, Inc.

Florham Park, NJ 07932

MADE IN JAPAN

Principal Display Panel

LARGE

3 15/16" X 5 1/2"

Hisamitsu

NDC#46581-675-99

for temporary relief of mild to moderate pain

Backache

Sore Muscle

Strains

Bruises

HOW TO APPLY

1 Peel the center film.

2 Place on affected area.

3 Slide a film.

4 Slide the other film.

Salonpas

Pain Relief 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

1 LARGE PATCH

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

Package not child resistant.

Keep out of reach of children.

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

Manufactured by

Hisamitsu Pharmaceutical Co., Inc.

JAPAN SAGA TOSU

MADE IN JAPAN

Distributed by

Hisamitsu America, Inc.

Florham Park, NJ 07932

FREE SAMPLE

NOT FOR RE-SALE

INGREDIENTS AND APPEARANCE

SALONPAS PAIN RELIEF

menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46581-675
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:46581-675-09	3 in 1 BOX	06/01/2018
1		3 in 1 POUCH; Type 0: Not a Combination Product
2	NDC:46581-675-01	1 in 1 POUCH; Type 0: Not a Combination Product	08/01/2020
3	NDC:46581-675-99	1 in 1 POUCH; Type 0: Not a Combination Product	05/15/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA022029	06/01/2018

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

Revised: 9/2021

Document Id: f74235b4-c91a-49d3-a02b-891a5ba2e068

Set id: acd7ba91-221a-485a-ad1f-dd41ed155656

Version: 5

Effective Time: 20210915

Search by Drug Name or NDC

NDC 46581-0675-09 Salonpas Pain Relief 63; 210 mg/1; mg/1 Details

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

Product Information

Package

Package Images

NDC 46581-0675-09 (46581067509)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL acd7ba91-221a-485a-ad1f-dd41ed155656 Details

Active ingredients (in each patch)

Purpose

Uses

Warnings

Stomach bleeding warning:

Do not use

Ask a doctor before use if

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive inredients

Questions or comments?

Principal Display Panel

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