SALONPAS DEEP RELIEVING- camphor, menthol, methyl salicylate gel

Salonpas DEEP Relieving by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Camphor 3.1%

Menthol 10.0%

Methyl salicylate 15.0%

Purpose

Topical analgesic

Uses

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

• simple backache
• sprains
• strains
• arthritis
• bruises

Warnings

For external use only

Allergy alert:

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Flammable:

Keep away from fire or flame.

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

Stop use and ask a doctor if

• conditions worsen
• skin reactions such are redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
• 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
• apply a dime sized portion to the affected area
• massage thoroughly until absorbed into skin
• apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: consult a doctor

Other information

• Avoid storing product in direct sunlight
• Protect product from excessive moisture
• Store at 20-25C (68-77F)
• Store with lid closed tightly

Inactive ingredients

ammonium acryloyldimethyltaurate/VP copolymer, dimethyl isosorbide, propylene glycol, SD alcohol 40-B, water

Questions or comments?

Toll free 1-800-826-8861

www.salonpas.us

Principal Display Panel

Hisamitsu

Non-Greasy Gel

Salonpas DEEP Relieving Gel

TOPICAL ANALGESIC

• 3 Powerful Pain Fighting Ingredients
• Fast-Acting
• Fast-Absorbing

MADE IN USA

2.75 OZ (78 g)

INGREDIENTS AND APPEARANCE

SALONPAS DEEP RELIEVING 
camphor, menthol, methyl salicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55328-900
Route of Administration	TOPICAL, PERCUTANEOUS, TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3.10 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10.00 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	15.00 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55328-900-02	1 in 1 BOX	06/01/2013
1		78 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2013

Labeler - Hisamitsu America, Inc. (191877802)