Avalin External Analgesic Patch
FDA Label NDC 33358-901

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rxchange Co. for the product Avalin External Analgesic Patch (NDC 33358-901). 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 active ingredients, purpose, uses, warnings, do not use, ask a doctor before use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Lidocaine 4%

Menthol 1%

Purpose

External Analgesic

Uses

For the temporary relief pain associated with • minor cuts  • scrapes  • minor skin imitations

Warnings

For external use only

Do Not Use

• in large quantities, particularly over raw surfaces or blistered areas

• other than directed by a doctor  • on open wounds or damaged skin

• with a bandage to cover the surface  • for longer than 5 consecutive days

Ask A Doctor Before Use

if used for children under 12.

When Using This Product

avoid contact with the eyes.

Stop Use And Ask A Doctor

• condition worsens  • symptoms persist for more than 7 days

• symptoms clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: Consult a doctor.
  • Clean and dry affected area.
  • Remove patch from backing and apply to affected area.
  • Use one patch at a time.
  • Leave patch on affected area for up to 8-hours at a time

Other Information

Store in dry area between 59-79 F(15-26 C)

Inactive Ingredients

acrylic acid, aluminum hydroxide, carmellose sodium, 2-ethylhexyl acrylate, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylate, polyacrylic acid, polysorbate 80, sorbitan sesquioleate, starch, talc, tartaric acid, titanium dioxide, water

Questions Or Comments?

Please call (818) 545-1177

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