Label: SALONPAS LIDOCAINE PLUS- benzyl alcohol, lidocaine hydrochloride liquid
- NDC Code(s): 55328-901-03
- Packager: Hisamitsu America, Inc.
- Category: HUMAN OTC DRUG LABEL
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
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- Active ingredients
- Purpose
- Uses
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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
- Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
SALONPAS LIDOCAINE PLUS
benzyl alcohol, lidocaine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55328-901 Route of Administration TOPICAL, PERCUTANEOUS, TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL 10.0000 g in 100 g LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4.0000 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) alcohol (UNII: 3K9958V90M) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55328-901-03 1 in 1 BOX 09/01/2017 1 80 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/01/2017 Labeler - Hisamitsu America, Inc. (191877802)