SALONPAS PAIN RELIEVING HOT- capsaicin, menthol 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 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

• use only 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

• skin reactions such as redness, itching, rash, excessive irritation, buring sensation, swelling or blistering occur
• 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 hour-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

edetate disodium, gelatin, glycerin, magnesium aluminometasilicate, methylacrylate/2-ethylhexyl acrylate copolymer, nonoxynol, oleyl alcohol, polyacrylic acid, polyvinyl alcohol, propylene glycol, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, water

Questions or comments?

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

Principal Display Panel

OTC topical analgesics in patch category*
WORLD'S BRAND NO.1

Hisamitsu

NDC#46581-871-06

for minor aches and pain relief

• Back
• Neck
• Shoulders
• Knees and Elbows

Salonpas Pain Relieving Gel-Patch HOT

Capsaicin 0.025%
Menthol 1.25%

APPLY FOR 8 HOURS

STRETCHABLE

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

MADE IN JAPAN

Principal Display Panel

IMPROVED ADHESION*1

Hisamitsu

NDC#46581-871-99

for minor aches and pain relief

• Back
• Neck
• Shoulders
• Knees and Elbows

Salonpas Pain Relieving Gel-Patch HOT

Capsaicin 0.025%, Menthol 1.25%

APPLY FOR 8 HOURS

STRETCHABLE

Better adhesion*2
Rounded corner

Easy application
Center-cut film

All direction stretchable

SAMPLE NOT FOR RE-SALE

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

MADE IN JAPAN

INGREDIENTS AND APPEARANCE

SALONPAS  PAIN RELIEVING HOT
capsaicin, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46581-871
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
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SILODRATE (UNII: 9T3UU8T0QK)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46581-871-06	2 in 1 BOX	01/01/2018
1		3 in 1 POUCH
1		7 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 46581-871-99	1 in 1 POUCH	11/01/2018
2		7 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	01/01/2018

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