Lidocaine LIDOCAINE PREFERRED PHARMACEUTICALS INC. FDA Approved Uses Temporarily relieves pain and itching associated with: • minor burns • sunburn • minor cuts • scrapes • insect bites • minor skin irritations
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Substance Lidocaine
Route
TOPICAL
Applications
505G(A)(3)
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Lidocaine 4%
Inactive Ingredients
Inactive ingredients Aqua (Deionized Water) Glycerin Sodium Polyacrylate Propylene Glycol Polysorbate 80 Tartaric Acid Dihydroxyaluminium Aminoacetate Methylparaben Peppermint Oil
Strengths
4 %
Quantities
1 count
Treats Conditions
Uses Temporarily Relieves Pain And Itching Associated With Minor Burns Sunburn Minor Cuts Scrapes Insect Bites Minor Skin Irritations

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
98PI200987
Packaging

PRINCIPAL DISPLAY PANEL Lidocaine 4% Patch NDC 68788-4029-1 10 Patches per Box Alexso, Inc Relabeled By: Preferred Pharmaceuticals Inc. Lidocaine 4% Patch

Package Descriptions
  • PRINCIPAL DISPLAY PANEL Lidocaine 4% Patch NDC 68788-4029-1 10 Patches per Box Alexso, Inc Relabeled By: Preferred Pharmaceuticals Inc. Lidocaine 4% Patch

Overview

Uses Temporarily relieves pain and itching associated with: • minor burns • sunburn • minor cuts • scrapes • insect bites • minor skin irritations

Indications & Usage

Uses Temporarily relieves pain and itching associated with: • minor burns • sunburn • minor cuts • scrapes • insect bites • minor skin irritations

Dosage & Administration

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

Warnings & Precautions
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.
Purpose

Purpose External analgesic

Do Not 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

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 & Ask a Doctor

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

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center immediately.

Storage & Handling

Other information Store at room temperature 15°-30°C (59°-86°F) Avoid storing product in direct sunlight and protect product from excessive moisture.


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