SPL v1
SPL
SPL Set ID 2e6278bb-ca55-70ff-e063-6294a90a6a58
Route
EXTRACORPOREAL
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (6 g)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Methylparaben Kaolin Glycerin Propylene Glycol Titanium Dioxide Povidone K90 Tartaric Acid Water Polysorbate 80 Propylparaben

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?

+1 818 579 7288

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?)

+1 818 579 7288

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)