AVERTEAX- zinc oxide and cocoa butter cream 
Camellix, LLC

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.

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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:

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.

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

Principal display panal

cm1 bottle label

cm1 carton label

AVERTEAX 
zinc oxide and cocoa butter cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54866-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.15 mg  in 1 g
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
SHEA BUTTER (UNII: K49155WL9Y)  
ALMOND OIL (UNII: 66YXD4DKO9)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Royal Jelly (UNII: L497I37F0C)  
EPIGALLOCATECHIN GALLATE STEARATES (UNII: MGB2NQG22C)  
EPIGALLOCATECHIN GALLATE PALMITATES (UNII: M213AC47MB)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54866-001-011 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/FEIBusiness Operations
Star Health and Beauty, LLC013506838manufacture(54866-001)

Revised: 3/2014
Document Id: 274fa9e5-6f94-4ac3-b952-0a7fdeebad45
Set id: 1e5ea5fd-4394-4b7c-bcbc-6c443d1135d7
Version: 1
Effective Time: 20140307
 
Camellix, LLC