Otc - Active Ingredient
Active ingredient Purpose
Zinc Oxide (0.015%) Cold Sores & Fever blisters
Cocoa Butter(0.25%) Cold Sores & Fever blisters
Averteax
FDA Label NDC 54866-001
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 54866-001). 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:, other information:, stop use if:, indications & usage:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Treatment for 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:
Apply daily as a lip moisturizer and protector for dryness, cold sores, or fever blisters. To achieve best results, apply at the first sign of symptoms (dryness, cracking) directly on the lip and affected area as needed.
Other Information:
During an outbreak, also use AverTeaX Topical Ointment for temporary relief of pain and itching.
Stop Use If:
Do not use if allergic to any ingredient of the product.
If condition worsens or does not improve after regular use of the product as directed, consult a doctor. If swallowed, contact a doctor.
Indications & Usage:
Indications are for relief of dryness, cold sores and fever blisters.
For relief of dryness, soften cold sores and fever blisters.
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:
Bees Wax, Shea Butter, Sweet Almond Oil, Vitamin E, Grape Seed Extract, Aloe Vera Extract, Royal Jelly, EGCG (Epigallocatechin-3-Gallate, Extracted from Green Tea) Stearate, EGCG Palmitate, Eucalyptus oil.
Package Label.Principal Display Panel
AVERTEAX DAILY LIP PROTECTOR FOR DRYNESS, COLD SORES & FEVER BLISTERS DISTRIBUTED BY CAMELLIX MADE IN USA
Principal Display Panal
Cm1 Bottle Label (Cm1bottlelabel)
Cm1 Carton Label (Cm1cartonlabel)
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