Label: SALONPAS LIDOCAINE PLUS- benzyl alcohol, lidocaine hydrochloride cream

  • NDC Code(s): 55328-902-03
  • 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 27, 2018

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredients

    Benzyl alcohol  10%

    Lidocaine HCl  4%

  • Purpose

    Topical anesthetic

  • Uses

    For temporary relief of pain

  • Warnings

    For external use only

    Do not use

    • on wounds or damaged skin
    • in large quantities
    • 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

    • skin reactions occur, such as rash, itching, redness, irritaion, pain, swelling and blistering
    • 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
    • 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 with lid closed tighly
  • Inactive ingredients

    aloe barbadensis leaf juice, aminomethyl propanol, butylene glycol, carbomer copolymer, cetearyl alcohol, ceteth phosphate, dicetyl phosphate, dimethicone, glyceryl monostearate, hydroxyl acrylate/sodium acryloyldimethyl taurate copolymer, polysorbate, SD alcohol 40-B, squalane, steareth, water

  • Questions or comments?

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

  • Principal Display Panel

    Hisamitsu

    NDC#55328-902-03

    Non-Greasy Cream

    Salonpas LIDOCAINE PLUS Pain Relieving Cream

    TOPICAL ANALGESIC

    4% LIDOCAIN MAXIMUM STRENGTH*1

    plus 10% Benzyl alcohol

    • 2 Powerful Anesthetics
    • Fast Acting
    • Numbing Relief
    • Unscented

    MADE IN USA

    3 OZ (85 g)

    image of 3 OZ tube

  • INGREDIENTS AND APPEARANCE
    SALONPAS LIDOCAINE PLUS 
    benzyl alcohol, lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55328-902
    Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL10.0000 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4.0000 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    alcohol (UNII: 3K9958V90M)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    SQUALANE (UNII: GW89575KF9)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55328-902-031 in 1 BOX06/23/2017
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/23/2017
    Labeler - Hisamitsu America, Inc. (191877802)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!