Averteax
FDA Label NDC 54866-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Camellix, Llc for the product Averteax (NDC 54866-002). 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 otc - active ingredient, purpose:, ask doctor:, warnings:, directions:, stop use:, indications & usage:, do not use:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient        Purpose
 Benzyl Alcohol (1.0%)     Cold Sores & Fever blisters

Purpose:

Treats cold sores and fever blisters, a vesicle that occurs at the junction of the mucous membrane and the skin on the lips or nose and is caused by the virus herpes simplex, type 1.

Ask Doctor:

If condition worsens or does not improve after regular use of the product as directed, consult a doctor.

If swallowed, contact a doctor.

Warnings:

For external use only.

Directions:

For the temporary relief of pain and itching of cold sores and fever blisters, apply AverTeaX ointment directly on the affected area throughout the day as needed. To achieve best result, apply at the frist sign of symptons (redness, tingling, tightness, or itching.)

Stop Use:

If illergic to any ingridient of the product.

Indications & Usage:

Indications are for pain and itching associated with fever blisters and cold sores.

For the temporary Relief of Pain and itching associated with fever blisters and cold sores.

Do Not Use:

If allergic to any ingredient of the product.

Keep Out Of Reach Of Children:

  • Keep out of reach of children.
  • If swallowed, contact a doctor. 

Inactive Ingredient

Ultrez 10 (Carbopol), Cetyl Alcohol (Powder Form), Stearic Acid, E. Glycol Stearate (EGMS), Glyceryl Stearate (GMS), Safflower Oil, Propylene Glycol USP, Glycerin (USP Grade) 99.7%, PMX-200 Silicone Fluid, Euxyl PE 9010 (0.5% - 1.0%), Aloe Vera, EGCG (Epigallocatechin-3-Gallate, Extracted from Green Tea) Stearate, EGCG Palmitate, Eucalyptus oil, Sodium Hyaluronate (Hyaluronic Acid), Lutein 10% (Marigold Ext. 10%), TEA (Triethanolamine)(99%).

Package Label.Principal Display Panel

AVERTEAX TOPICAL OINTMENT COLD SORES AND FEVER BLISTERS TREATMENT DISTRIBUTED BY CAMELLIX MADE IN USA

Principal Display Panal

Cm1 Bottle Label (Cm1bottlelabel)

Cm1 Bottle Label (Cm1bottlelabel)

Cm1 Carton Label (Cm1cartonlabel)

Cm1 Carton Label (Cm1cartonlabel)

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