Lidocaine by Alexso, Inc LIDOCAINE patch

Lidocaine by

Drug Labeling and Warnings

Lidocaine by is a Otc medication manufactured, distributed, or labeled by Alexso, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

LIDOCAINE – Lidocaine 4% Patch

Alexso, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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, Dihydroxyaluminium Aminoacetate, Methylparaben, Peppermint Oil

PRINCIPAL DISPLAY PANEL

Lidocaine 4% Patch

NDC: 50488-2004-1

10 Patches per Box

Alexso, Inc

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50488-2004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 1 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)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50488-2004-1	10 in 1 CARTON	01/15/2020
1		100 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 NOT FINAL	part348	01/15/2020

Labeler - Alexso, Inc (963338061)