SPL v5
SPL
SPL Set ID 364924d3-fac3-4f4e-9b40-decd4ec48245
Routes
TOPICAL PERCUTANEOUS TRANSDERMAL
Published
Effective Date 2024-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzyl Alcohol (10.0000 g)
Inactive Ingredients
Aloe Vera Leaf Aminomethylpropanol Butylene Glycol Cetostearyl Alcohol Dihexadecyl Phosphate Alcohol Tert-butyl Alcohol Denatonium Benzoate Squalane Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-06-23

Description

Benzyl alcohol  10% Lidocaine HCl  4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Benzyl alcohol  10% Lidocaine HCl  4%

Uses

For temporary relief of pain

Warnings

For external use only

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

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
Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Store with lid closed tighly
Active Ingredients

Benzyl alcohol  10%

Lidocaine HCl  4%

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)

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.


Structured Label Content

Uses

For temporary relief of pain

Purpose

Topical anesthetic

Warnings

For external use only

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

Do Not Use (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
Other Information (Other information)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Store with lid closed tighly
Active Ingredients (Active ingredients)

Benzyl alcohol  10%

Lidocaine HCl  4%

Inactive Ingredients (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? (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)

When Using 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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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