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AVERTEAX by Camellix, LLC

Dosage form: ointment
Ingredients: ZINC OXIDE 0.15mg in 1g, COCOA BUTTER 2.5mg in 1g
Labeler: Camellix, LLC
NDC Code: 54866-003

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.

AVERTEX Zinc Oxide & Cocoa Butter

Active ingredient        Purpose
Zinc Oxide (0.015%)     Cold Sores & Fever blisters
Cocoa Butter(0.25%)    Cold Sores & Fever blisters

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:

Sweet Almond Oil, Grape Seed Oil,  Bees Wax, Shea Butter, Aloe Vera Extract, Royal Jelly, EGCG (Epigallocatechin-3-Gallate, Extracted from Green Tea) Stearate, EGCG Palmitate, Vitamin E, Eucalyptus oil.

AVERTEAX DAILY LIP PROTECTOR FOR DRYNESS, COLD SORES & FEVER BLISTERS DISTRIBUTED BY CAMELLIX MADE IN USA

Principal display panal

AVERTEAX 
zinc oxide and cocoa butter ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54866-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.15 mg  in 1 g
COCOA BUTTER (COCOA BUTTER) COCOA BUTTER2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALMOND OIL 
GRAPE SEED OIL 
YELLOW WAX 
SHEA BUTTER 
ALOE VERA LEAF 
Royal Jelly 
EPIGALLOCATECHIN GALLATE STEARATES 
EPIGALLOCATECHIN GALLATE PALMITATES 
.ALPHA.-TOCOPHEROL 
EUCALYPTUS OIL 
Packaging
#Item CodePackage Description
1NDC:54866-003-011 TUBE in 1 PACKAGE
14.2 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2014
Labeler - Camellix, LLC (968429386)
Establishment
NameAddressID/FEIOperations
Star Health and Beauty, LLC013506838manufacture(54866-003)

Revised: 03/2014
 
Camellix, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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