FDA.reportPublic FDA data

AVERTEAX

Manufacturer
Camellix, LLC | Star Health and Beauty, LLC
Effective date
2014-03-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:39:23

Label at a glance#

ProductAVERTEAX
Active ingredientZINC OXIDE, COCOA BUTTER
Label structure13 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient        Purpose
Zinc Oxide (0.015%)     Cold Sores & Fever blisters
Cocoa Butter(0.25%)    Cold Sores & Fever blisters

PURPOSE:

OTC - PURPOSE SECTION

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:

OTC - ASK DOCTOR SECTION

If condition worsens or does not improve after regular use of the product as directed, consult a doctor.

If swallowed, contact a doctor.

WARNINGS:

WARNINGS SECTION

For external use only.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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:

SPL UNCLASSIFIED SECTION

During an outbreak, also use AverTeaX Topical Ointment for temporary relief of pain and itching.

STOP USE IF:

OTC - STOP USE SECTION

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 & USAGE SECTION

Indications are for relief of dryness, cold sores and fever blisters.

For relief of dryness, soften cold sores and fever blisters.

DO NOT USE:

OTC - DO NOT USE SECTION

If allergic to any ingredient of the product.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INACTIVE INGREDIENT:

INACTIVE INGREDIENT SECTION

Sweet Almond Oil, Grape Seed Oil,  Bees Wax, Shea Butter, Aloe Vera Extract, Royal Jelly, EGCG (Epigallocatechin-3-Gallate, Extracted from Green Tea) Stearate, EGCG Palmitate, Vitamin E, Eucalyptus oil.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Principal display panal

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cm3bottle labelcm3bottle label

cm3carton labelcm3carton label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54866-003-012019-11-27C16284748780-19855e2a2-32d0-60a7-e053-dbdaa90a05bdAVERTEX Zinc Oxide & Cocoa Butter

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54866-003-01AVERTEAX1 in 1 PACKAGEOINTMENT11
54866-003-01AVERTEAX4.2 g in 1 TUBEOINTMENT4.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54866-003AVERTEAX (ZINC OXIDE AND COCOA BUTTER) OINTMENT [CAMELLIX, LLC]1Legacy NDC, 2 package rows20140523_339576cb-8ec5-4da9-9c5c-daaed1610a5b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
COCOA BUTTERACTIVE INGREDIENT512OYT1CRR1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
COCOA BUTTERACTIVE MOIETY512OYT1CRR1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
ALMOND OILINACTIVE INGREDIENT66YXD4DKO91
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
EPIGALLOCATECHIN GALLATE PALMITATESINACTIVE INGREDIENTM213AC47MB1
EPIGALLOCATECHIN GALLATE STEARATESINACTIVE INGREDIENTMGB2NQG22C1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6621
GRAPE SEED OILINACTIVE INGREDIENT930MLC8XGG1
Royal JellyINACTIVE INGREDIENTL497I37F0C1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54866-00354866-003-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
COCOA BUTTER512OYT1CRRACTIB
ALMOND OIL66YXD4DKO9IACT
GRAPE SEED OIL930MLC8XGGIACT
YELLOW WAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
ALOE VERA LEAFZY81Z83H0XIACT
Royal JellyL497I37F0CIACT
EPIGALLOCATECHIN GALLATE STEARATESMGB2NQG22CIACT
EPIGALLOCATECHIN GALLATE PALMITATESM213AC47MBIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
EUCALYPTUS OIL2R04ONI662IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii candidate
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
ALMOND OILALMOND OIL66YXD4DKO9CREAM / TOPICAL2 %w/wExact identifier — unii candidate
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0c133233-1646-4889-a4ec-a3c86c03e402339576cb-8ec5-4da9-9c5c-daaed1610a5b2014-03-08WarningsExact identifier
spl id: 0c133233-1646-4889-a4ec-a3c86c03e402
spl set id: 339576cb-8ec5-4da9-9c5c-daaed1610a5b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.