SALONPAS PAIN RELIEVING HOT LARGE- capsaicin 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 ingredient

Capsicum extract 0.025% as Capsaicin

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
peel 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, butylated hydroxytoluene, hydrogenated rosin glycerol ester, maleated rosin glycerin ester, mineral oil, polyisobutylene, polyisobutylene 1,200,000, styrene-isoprene-styrene block copolymer

Questions or comments?

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

Principal Display Panel

Cut open easily by hand

LARGE

NDC#46581-750-01

for minor aches and pain relief

Shoulder
Upper Back
Lower Back
1 Peel the center film.

2 Place on affected area.

3 Slide a film.

4 Slide the other film.

Salonpas pain relieving PATCH HOT LARGE

Pain Relieving Ointment on a Breathable Cloth

Capsaicin 0.025%

LASTS UP TO 8 HOURS

STRETCHABLE and FLEXIBLE

1 LARGE patch

Hisamitsu

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

Manufactured by

Hisamitsu Pharmaceutical Co., Inc.

JAPAN SAGA TOSU

MADE IN JAPAN

Distributed by

Hisamitsu America, Inc.

Florham Park, NJ 07932

image of 1-patch pouch label

SALONPAS PAIN RELIEVING HOT LARGE
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46581-750
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

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM SILICATE (UNII: T1FAD4SS2M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MINERAL OIL (UNII: T5L8T28FGP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:46581-750-03	1 in 1 BOX	01/01/2012	05/31/2020
1		3 in 1 POUCH
1		2.10 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC:46581-750-01	1 in 1 POUCH	01/01/2012	05/31/2020
2		2.10 g in 1 PATCH; Type 0: Not a Combination Product
3	NDC:46581-750-99	1 in 1 POUCH	01/01/2012	05/31/2020
3		2.10 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	01/01/2012	05/31/2020

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

Revised: 9/2021

Document Id: 072c75a4-d64e-483b-a6c4-d829ffa49235

Set id: b3b35d6c-d752-4e5e-872f-23f338c1c567

Version: 8

Effective Time: 20210915

Hisamitsu Pharmaceutical Co., Inc.