Label: AVERTEAX- benzyl alcohol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 7, 2014

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  • 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%).

  • PRINCIPAL DISPLAY PANEL

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

  • Principal display panal

    cm1 bottle label

    cm1 carton label

  • INGREDIENTS AND APPEARANCE
    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)
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