SPL v2
SPL
SPL Set ID 9507f727-c49f-4de4-9d64-b6d977d568ab
Routes
TOPICAL PERCUTANEOUS TRANSDERMAL
Published
Effective Date 2024-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (42 mg)
Inactive Ingredients
Aluminum Silicate Mineral Oil Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-01

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 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
  • peel film from patch and apply to the skin (see illustration)
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Do Not Use
  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any igredients of this product
Active Ingredient

Lidocaine 4%

Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Inactive Ingredients

aluminum silicate, mineral oil, polyisobutylene, propylene glycol, styrene-isoprene-styrene block copolymer, terpene resin

Questions Or Comments?

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

Principal Display Panel

OTC topical analgesics in patch category

WORLD’S BRAND NO.1

Hisamitsu

NDC#46581-840-07

for temporary relief of pain

PATCH CONTOURS TO YOUR BODY

Adheres as you move, bend, twist, or flex

Salonpas Pain Relieving FLEX Patch LIDOCAINE 4%

APPLY FOR UP TO 8 HOURS

MAXIMUM OTC STRENGTH

• Stretchable

• Thin Fabric

• Strong Adhesion

7 PATCHES

2 3/4" X 3 15/16" (7cm X 10cm)

MADE IN JAPAN

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 such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
  • 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
  • peel film from patch and apply to the skin (see illustration)
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Do Not Use (Do not use)
  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any igredients of this product
Active Ingredient (Active ingredient)

Lidocaine 4%

Other Information (Other information)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Inactive Ingredients (Inactive ingredients)

aluminum silicate, mineral oil, polyisobutylene, propylene glycol, styrene-isoprene-styrene block copolymer, terpene resin

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

OTC topical analgesics in patch category

WORLD’S BRAND NO.1

Hisamitsu

NDC#46581-840-07

for temporary relief of pain

PATCH CONTOURS TO YOUR BODY

Adheres as you move, bend, twist, or flex

Salonpas Pain Relieving FLEX Patch LIDOCAINE 4%

APPLY FOR UP TO 8 HOURS

MAXIMUM OTC STRENGTH

• Stretchable

• Thin Fabric

• Strong Adhesion

7 PATCHES

2 3/4" X 3 15/16" (7cm X 10cm)

MADE IN JAPAN

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 such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
  • 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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