SPL v2
SPL
SPL Set ID 2e531194-67ad-c645-e063-6394a90a916c
Route
EXTRACORPOREAL
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (37 g)
Inactive Ingredients
Water Glycerin Propylparaben Methylparaben Polysorbate 80 Dihydroxyaluminum Aminoacetate Anhydrous Tartaric Acid Titanium Dioxide Povidone K90 Kaolin Propylene Glycol

Identifiers & Packaging

Pill Appearance
Size: 140 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-01

Description

Lidocaine 4.0% Purpose Topical anesthetic


Medication Information

Description

Lidocaine 4.0% Purpose Topical anesthetic

Use

For temporary relief of pain

Section 51945-4

Warnings

​For external use only



Do not use



more than 1 patch at a time

with a heating pad

on wounds or damaged skin

ir you are allergic to any ingredients of this product



When using this product



use only as directed

do not bandage tightly

avoid contact with the eyes, mucous membranes or rashes



Stop use and ask a doctor if



symptoms persist for more than 7 days

conditions worsen

symptoms clear up and occur again within a few days

localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop



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 1 patch at a time to affected area, not more than 3 to 4 times daily

remove film from patch and apply to the skin



Children under 12 years of age: consult a doctor

Questions?

​1-888-655-1558

Active Ingredient

Lidocaine 4.0%



Purpose



Topical anesthetic

Other Information

​store in a clean, dry place outside of direct sunlight, Protect product from excessive moisture

Inactive Ingredients

​Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone K90, Propylene Glycol, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water


Structured Label Content

Use (USE)

For temporary relief of pain

Section 51945-4 (51945-4)

Warnings (WARNINGS)

​For external use only



Do not use



more than 1 patch at a time

with a heating pad

on wounds or damaged skin

ir you are allergic to any ingredients of this product



When using this product



use only as directed

do not bandage tightly

avoid contact with the eyes, mucous membranes or rashes



Stop use and ask a doctor if



symptoms persist for more than 7 days

conditions worsen

symptoms clear up and occur again within a few days

localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop



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 (DIRECTIONS)

​Adults and children 12 years of age and over:



clean and dry affected area

apply 1 patch at a time to affected area, not more than 3 to 4 times daily

remove film from patch and apply to the skin



Children under 12 years of age: consult a doctor

Questions? (QUESTIONS?)

​1-888-655-1558

Active Ingredient (ACTIVE INGREDIENT)

Lidocaine 4.0%



Purpose



Topical anesthetic

Other Information (OTHER INFORMATION)

​store in a clean, dry place outside of direct sunlight, Protect product from excessive moisture

Inactive Ingredients (INACTIVE INGREDIENTS)

​Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone K90, Propylene Glycol, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)