Lidocaine — v1

Lidocaine

5 Views

Version

v1

Effective date

September 22, 2025

Original packager

Sections captured

14

Identifiers

Document ID
2310b6ae-cacf-4b29-9b03-7f42849dfc18
Set ID
2310b6ae-cacf-4b29-9b03-7f42849dfc18
Application numbers
505G(a)(3)
Product NDCs
68788-4029
Package NDCs
68788-4029-1
Original packager NDCs
50488-2004

Names & Manufacturers

Brand names
Lidocaine
Generic names
LIDOCAINE
Manufacturer names
Preferred Pharmaceuticals Inc.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
LIDOCAINE
Routes
TOPICAL
Pharmacologic class (PE)
Local Anesthesia [PE]
Pharmacologic class (EPC)
Amide Local Anesthetic [EPC], Antiarrhythmic [EPC]
Pharmacologic class (CS)
Amides [CS]
Mechanism of action

Other identifiers

NUI
M0000897, N0000175426, N0000175682, N0000175976
RxCUI
UNII
98PI200987
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Lidocaine 4%
Do Not Use (1)

Sequence 1

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.
Dosage And Administration (1)

Sequence 1

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
Inactive Ingredient (1)

Sequence 1

Inactive ingredients Aqua (Deionized Water), Glycerin, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben, Peppermint Oil
Indications And Usage (1)

Sequence 1

Uses Temporarily relieves pain and itching associated with: • minor burns • sunburn • minor cuts • scrapes • insect bites • minor skin irritations
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center immediately.
Package Label Principal Display Panel (1)

Sequence 1

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

Sequence 1

Purpose External analgesic
Spl Product Data Elements (1)

Sequence 1

Lidocaine Lidocaine LIDOCAINE LIDOCAINE WATER GLYCERIN PROPYLENE GLYCOL POLYSORBATE 80 TARTARIC ACID DIHYDROXYALUMINUM AMINOACETATE METHYLPARABEN PEPPERMINT OIL SODIUM POLYACRYLATE (8000 MW)
Spl Unclassified Section (1)

Sequence 1

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. ---------- Lidocaine 4% Patch Drug Facts
Stop Use (1)

Sequence 1

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.
Storage And Handling (1)

Sequence 1

Other information Store at room temperature 15°-30°C (59°-86°F) Avoid storing product in direct sunlight and protect product from excessive moisture.
Warnings (1)

Sequence 1

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.
When Using (1)

Sequence 1

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

OpenFDA raw payload

{'application_number': ['505G(a)(3)'],
 'brand_name': ['Lidocaine'],
 'generic_name': ['LIDOCAINE'],
 'manufacturer_name': ['Preferred Pharmaceuticals Inc.'],
 'nui': ['N0000175682', 'M0000897', 'N0000175426', 'N0000175976'],
 'original_packager_product_ndc': ['50488-2004'],
 'package_ndc': ['68788-4029-1'],
 'pharm_class_cs': ['Amides [CS]'],
 'pharm_class_epc': ['Amide Local Anesthetic [EPC]', 'Antiarrhythmic [EPC]'],
 'pharm_class_pe': ['Local Anesthesia [PE]'],
 'product_ndc': ['68788-4029'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['2310b6ae-cacf-4b29-9b03-7f42849dfc18'],
 'spl_set_id': ['2310b6ae-cacf-4b29-9b03-7f42849dfc18'],
 'substance_name': ['LIDOCAINE'],
 'unii': ['98PI200987']}