SALONPAS LIDOCAINE PLUS- benzyl alcohol, lidocaine hydrochloride liquid

Salonpas LIDOCAINE PLUS by

Drug Labeling and Warnings

Salonpas LIDOCAINE PLUS by is a Otc medication manufactured, distributed, or labeled by Hisamitsu America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Benzyl alcohol  10%

Lidocaine HCl  4%

Purpose

Topical anesthetic

Uses

For temporary relief of pain

Warnings

For external use only

Flammable:

Keep away from fire or flame

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, carbomer, SD alcohol 40-B, water

Questions or comments?

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

Principal Display Panel

Hisamitsu

NDC#55328-901-03

No-Mess Roll On

Salonpas LIDOCAINE PLUS Pain Relieving Liquid

TOPICAL ANALGESIC

4% LIDOCAIN MAXIMUM STRENGTH *1
plus 10% Benzyl alcohol

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

MADE IN USA

3 FL OZ (88 mL)

INGREDIENTS AND APPEARANCE

SALONPAS LIDOCAINE PLUS 
benzyl alcohol, lidocaine hydrochloride liquid

Product 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)