SALONPAS PAIN RELIEF- menthol, methyl salicylate patch

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
Hisamitsu Pharmaceutical Co., Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical analgesic Temporarily relieves mild to moderate aches and pains of muscles and joints associated with: - strains - sprains - simple backache - arthritis - bruises
Authorization status:
New Drug Application
Authorization number:
46581-675-01, 46581-675-09, 46581-675-99

SALONPAS PAIN RELIEF- menthol, methyl salicylate patch

Hisamitsu Pharmaceutical Co., Inc.

----------

Active ingredients (in each patch)

Menthol 3%

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

Purpos e

Topical analgesic

Us es

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 doctor before use while breast-feeding and during the first 6 months of pregnancy. Do not use

during the last 3 months of pregnancy

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

SALONPAS PAIN RELIEF

menthol, methyl salicylate patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:46 58 1-6 75

Route of Administration

TOPICAL, PERCUTANEOUS, TRANSDERMAL

Active Ingredient/Active Moiety

Hisamitsu Pharmaceutical Co., Inc.

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

6 3 mg

METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

METHYL SALICYLATE

210 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ALUMINUM SILICATE (UNII: T1FAD4SS2M)

MINERAL O IL (UNII: T5L8 T28 FGP)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:46 58 1-6 75-0 9

3 in 1 BOX

0 6 /0 1/20 18

1

3 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:46 58 1-6 75-0 1

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 1/20 20

3

NDC:46 58 1-6 75-9 9

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 5/15/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 220 29

0 6 /0 1/20 18

Labeler -

Hisamitsu Pharmaceutical Co., Inc. (690539713)

Revised: 8/2020

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