AVERTEAX- benzyl alcohol  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 Benzyl Alcohol

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:

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%).

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

Principal display panal

cm1 bottle label

cm1 carton label

AVERTEAX 
benzyl alcohol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54866-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Safflower Oil (UNII: 65UEH262IS)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Glycerin (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EPIGALLOCATECHIN GALLATE STEARATES (UNII: MGB2NQG22C)  
EPIGALLOCATECHIN GALLATE PALMITATES (UNII: M213AC47MB)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
Hyaluronic Acid (UNII: S270N0TRQY)  
LUTEIN (UNII: X72A60C9MT)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54866-002-011 in 1 PACKAGE
17.4 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(54866-002)

Revised: 3/2014
Document Id: dea0cd6a-9743-4539-a694-c88cf3543525
Set id: f86b5de9-8e44-4d06-890e-75f7e71c79e4
Version: 1
Effective Time: 20140307
 
Camellix, LLC