Salonpas DEEP Relieving Gel TOPICAL ANALGESIC

SALONPAS DEEP RELIEVING TOPICAL ANALGESIC - camphor (natural), menthol and methyl salicylate gel 
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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Salonpas DEEP Relieving Gel TOPICAL ANALGESIC

Salonpas DEEP Relieving Gel TOPICAL ANALGESIC


Active Ingredients

Camphor 3.1%
Menthol 10%
Methyl Salicylate 15%

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

  • do not bandage tightly
  • do not use otherwise than as directed
  • avoid contact with eyes, mucous membranes or rashes

Stop use and ask a doctor if

  • conditions worsen
  • rash, itching or excessive skin irritation develops
  • symptoms persists 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 20-25 degree C (68-77 degree F)
  • 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, Weekdays, 9AM to 5PM (EST)
www.salonpas.us

Distributed by Hisamitsu America, Inc., Florham Park, NJ 07932
Salonpas is a trade mark of Hisamitsu Pharmaceutical Co., Inc.

For minor aches and pains:

  • Backache
  • Stiff Neck
  • Joint Pain
  • Sore Muscle

Salonpas DEEP Relieving Gel  TOPICAL ANALGESIC

LASTS UPTO 8 HOURS

Hisamitsu

NET WT 2.75 OZ (78g)

Salonpas DEEP Relieving Gel TOPICAL ANALGESIC 2.75oz/78g (46581-200-00)

Outer Label

SALONPAS DEEP RELIEVING TOPICAL ANALGESIC  
camphor, menthol, methyl salicylate gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:46581-200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)31 mg  in 1 g
MENTHOL (MENTHOL) MENTHOL100 mg  in 1 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
AMMONIUM ACRYLOYLDIMETHYLTAURATE 
DIMETHYL ISOSORBIDE 
PROPYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46581-200-001 in 1 PACKAGE
178 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/14/201312/27/2013
Labeler - Hisamitsu Pharmaceutical Co., Inc (690539713)
Establishment
NameAddressID/FEIBusiness Operations
Formulated Solutions, LLC143266687manufacture(46581-200)

Revised: 12/2013
 
Hisamitsu Pharmaceutical Co., Inc