LIDOCAINE 4 PERCENT- lidocaine patch

Lidocaine 4 Percent by

Drug Labeling and Warnings

Lidocaine 4 Percent by is a Otc medication manufactured, distributed, or labeled by ARI BRANDS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Lidocaine 4% Patch

Drug Facts

Active ingredient

Lidocaine 4%

Purpose

External analgesic

Uses

Temporarily relieves pain and itching associated with:

minor burns

sunburn

minor cuts

scrapes

insect bites

minor skin irritations

Warnings

For external use only.

Read all warnings and directions before use.

Do not use

More than one patch at a time

On wounds or damaged skin

With a heating pad

If you are allergic to any ingredients of this product

Allergy Alert: if you are allergic to any inactive ingredient of this product, contact a doctor before use.

When using this product

Use only as directed. 

 Avoid contact with eyes, mucous membranes, or rashes

Do not tightly wrap or bandage the treated area

Stop use and ask a physician:

If pregnant or breast feeding

If localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Keep out of reach of children and pets.

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

Directions

Adults and children 12 years of age and older:

Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.
- Clean and dry the affected area.
- Open pouch and remove one patch.
- Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.
- Wash hands with soap and water after handling the patches.
- Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
- Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.

Children under 12 years: Ask a physician

Other information

Store at room temperature 15°-30°C (59°-86°F)

Avoid storing product in direct sunlight and protect product from excessive moisture.

Inactive ingredients

Aqua (Deionized Water), Glycerin, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminum Aminoacetate, Methylparaben, Peppermint Oil

PRINCIPAL DISPLAY PANEL

Lidocaine 4% Patch

NDC: 71436-3104-1

10 Patches per Box

AriBrands, LLC

INGREDIENTS AND APPEARANCE

LIDOCAINE 4 PERCENT 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71436-3104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TARTARIC ACID (UNII: W4888I119H)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71436-3104-1	10 in 1 BOX	10/01/2023
1		1 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/01/2023

Labeler - ARI BRANDS, LLC (080658382)