Lidall
FDA Label NDC 64533-000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medvantage Pharmaceutical, Llc for the product Lidall (NDC 64533-000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding warnings, active ingredients, inactive ingredients, otc - keep out of reach of children, directions, purpose, use, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Warnings

For external use only

Do not use

■ other than directed

 ■ on wounds

 ■ on damaged skin

■if you are allergic to menthol

 ■ in large quantities, particularly over raw services or blistered areas

When using this product

■ avoid contact with the eyes or mucous membranes

■ do not bandage tightly

Stop use and ask a doctor

■ excessive irritation of the skin develops

 ■ condition worsens

■symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

Active Ingredients

Lidocaine 4%

Menthol 1%

Inactive Ingredients

Aloe (Aloe Barbadensis) Leaf Juice, Diazolidinyl Urea, EDTA Disodium Salt, Glycerin, Iodopropynyl Butylcarbamate,

Methylparaben, Polysorbate 80, Propylparaben, Sodium Polyacrylate, Water

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

Directions

■Clean and dry affected area. Cut open pouch and remove patch.

■Remove protective film and apply directly to affected area.

■Wash hands with soap after applying patch.

■Reseal pouch containing unused patches.

■Adults and children 12 years of age and older: Apply to affected area; change patch 1 to 2 times daily. Do not apply

to affected are more than 3 times daily.

■Children under 12 years of age: Consult a physician before use.

Purpose

Pain relief

Use

■For the temporary relief of pain and itching associated with minor skin irritations.

Other Information

Store below 77 ° F (25° C). Avoid direct sunlight.

* Please review the disclaimer below.