Label: SALONPAS DEEP RELIEVING- camphor, menthol, methyl salicylate gel

  • NDC Code(s): 55328-900-02
  • Packager: Hisamitsu America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated November 28, 2018

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  • 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)

    image of 78g box label

  • INGREDIENTS AND APPEARANCE
    SALONPAS DEEP RELIEVING 
    camphor, menthol, methyl salicylate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55328-900
    Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.10 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10.00 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15.00 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55328-900-021 in 1 BOX06/01/2013
    178 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2013
    Labeler - Hisamitsu America, Inc. (191877802)
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