SALONPAS DEEP RELIEVING (CAMPHOR, MENTHOL, METHYL SALICYLATE) GEL [HISAMITSU AMERICA, INC.]

SALONPAS DEEP RELIEVING (CAMPHOR, MENTHOL, METHYL SALICYLATE) GEL [HISAMITSU AMERICA, INC.]
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NDC 55328-900-02
Set ID a4ddb2b9-d023-4c8c-9285-93d51f93207d
Category HUMAN OTC DRUG LABEL
Packager Hisamitsu America, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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