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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient        Purpose
     Benzyl Alcohol (1.0%)     Cold Sores & Fever blisters

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  • 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.

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  • 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.

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  • WARNINGS:

    For external use only.

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  • 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.)

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  • STOP USE:

    If illergic to any ingridient of the product.

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  • 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.

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  • DO NOT USE:

    If allergic to any ingredient of the product.

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  • KEEP OUT OF REACH OF CHILDREN:

    • Keep out of reach of children.
    • If swallowed, contact a doctor. 
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  • 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%).

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  • PRINCIPAL DISPLAY PANEL

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

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  • Principal display panal
  • INGREDIENTS AND APPEARANCE
    AVERTEAX 
    benzyl alcohol cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54866-002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54866-002-01 1 in 1 PACKAGE
    1 7.4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/01/2014
    Labeler - Camellix, LLC (968429386)
    Establishment
    Name Address ID/FEI Business Operations
    Star Health and Beauty, LLC 013506838 manufacture(54866-002)
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