Label: AVERTEAX- zinc oxide and cocoa butter 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
    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:

    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.

  • PRINCIPAL DISPLAY PANEL

    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

  • INGREDIENTS AND APPEARANCE
    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)
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