SALONPAS LIDOCAINE PLUS- benzyl alcohol, lidocaine hydrochloride cream 
Hisamitsu America, 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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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:

Children under 12 years of age:

consult a doctor

Other information

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

MADE IN USA

3 OZ (85 g)

image of 3 OZ tube

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)

Revised: 11/2018
Document Id: 839462af-c649-444a-aa29-2bf5f831b081
Set id: 364924d3-fac3-4f4e-9b40-decd4ec48245
Version: 4
Effective Time: 20181127
 
Hisamitsu America, Inc.