SALONPAS PAIN RELIEVING HOT LARGE- capsaicin patch

Salonpas by

Drug Labeling and Warnings

Salonpas by is a Otc medication manufactured, distributed, or labeled by Hisamitsu Pharmaceutical Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SALONPAS  PAIN RELIEVING HOT LARGE
capsaicin patch

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

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

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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2012

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