Salonpas Lidocaine Plus (Benzyl Alcohol, Lidocaine Hydrochloride) Cream [Hisamitsu America, Inc.] -

SALONPAS LIDOCAINE PLUS (BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE) CREAM [HISAMITSU AMERICA, INC.]
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NDC	55328-902-03
Set ID	364924d3-fac3-4f4e-9b40-decd4ec48245
Category	HUMAN OTC DRUG LABEL
Packager	Hisamitsu America, Inc.
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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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:
- 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)

INGREDIENTS AND APPEARANCE

SALONPAS LIDOCAINE PLUS
benzyl alcohol, lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55328-902
Route of Administration	TOPICAL, PERCUTANEOUS, TRANSDERMAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55328-902-03	1 in 1 BOX	06/23/2017
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/23/2017

Labeler - Hisamitsu America, Inc. (191877802)

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Medic

SALONPAS LIDOCAINE PLUS (BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE) CREAM [HISAMITSU AMERICA, INC.]

Do not use

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

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