Salonpas by Hisamitsu Pharmaceutical Co., Inc.

Drug Details [pdf]

SALONPAS PAIN RELIEVING HOT- capsaicin, menthol 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

Capsicum extract 0.025% as Capsaicin

Menthol 1.25%

Purpose

Topical analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

simple backache
arthritis
strains
bruises
sprains

Warnings

For external use only

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
discontinue use at least 1 hour before a bath or shower
do not use immediately after a bath or shower

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 film from patch and apply to the skin (see illustration)
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

aluminum silicate, edetate disodium, gelatin, glycerin, magnesium aluminometasilicate, oleyl alcohol, polyacrylic acid, polyethylene glycol, polyvinyl alcohol, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, water

Questions or comments?

Toll free 1-800-826-8861 www.salonpas.us

Principal Display Panel

Hisamitsu

NDC#46581-870-06

for minor aches and pain relief

Shoulder
Upper Back
Lower Back

Salonpas pain relieving GEL-PATCH HOT

Capsaicin 0.025%

Menthol 1.25%

LASTS UP TO 8 HOURS

Pain Relieving Ointment on a Breathable Cloth

STRETCHABLE

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

image of 6-patch box label

Principal Display Panel

image of 1-patch sample pouch label

NDC#46581-870-99

for minor aches and pain relief

Shoulder
Upper Back
Lower Back

1 Pull apart.

2 Place on affected area.

3 Slide the both films.

4 Gently apply the patch.

Salonpas pain relieving GEL-PATCH HOT

Capsaicin 0.025%

Menthol 1.25%

LASTS UP TO 8 HOURS

Pain Relieving Ointment on a Breathable Cloth

STRETCHABLE

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

Hisamitsu

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 RELIEVING HOT
capsaicin, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46581-870
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSAICIN	0.025 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
GELATIN (UNII: 2G86QN327L)
POLYVINYL ALCOHOL (UNII: 532B59J990)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALUMINUM SILICATE (UNII: T1FAD4SS2M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 46581-870-06	2 in 1 BOX	05/01/2011	12/31/2019
1		3 in 1 POUCH
1		14 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 46581-870-01	1 in 1 POUCH	05/01/2011	12/31/2019
2		14 g in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 46581-870-99	1 in 1 POUCH	05/01/2011	12/31/2019
3		14 g in 1 PATCH; 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	05/01/2011	12/31/2019

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

Revised: 12/2019

Document Id: b5fc9686-5b3c-496a-a87c-b88bd5b861ac

Set id: ee0ec612-3abd-4365-bfd4-9fa69abf0186

Version: 11

Effective Time: 20191217

Hisamitsu Pharmaceutical Co., Inc.