FDA.reportPublic FDA data

AVERTEAX

Manufacturer
Camellix, LLC | Star Health and Beauty, LLC
Effective date
2014-03-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:39:14

Label at a glance#

ProductAVERTEAX
Active ingredientBENZYL ALCOHOL
Label structure12 sections

Dosage and administration

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.)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

PURPOSE:

OTC - PURPOSE SECTION

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:

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

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:

OTC - STOP USE SECTION

If illergic to any ingridient of the product.

INDICATIONS & USAGE:

INDICATIONS & USAGE SECTION

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:

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

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%).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Principal display panal

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cm1 bottle labelcm1 bottle label

cm1 carton labelcm1 carton label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZYL ALCOHOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54866-002-012019-11-27C16284748780-19855e2a2-3aaa-60a7-e053-dbdaa90a05bdAVERTEX Benzyl Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54866-002-01AVERTEAX7.4 g in 1 TUBECREAM7.41
54866-002-01AVERTEAX1 in 1 PACKAGECREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54866-002AVERTEAX (BENZYL ALCOHOL ) CREAM [CAMELLIX, LLC]1Legacy NDC, 2 package rows20140507_f86b5de9-8e44-4d06-890e-75f7e71c79e4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZYL ALCOHOLACTIVE INGREDIENTLKG8494WBH1
BENZYL ALCOHOLACTIVE MOIETYLKG8494WBH1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YD1
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995L1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
EPIGALLOCATECHIN GALLATE PALMITATESINACTIVE INGREDIENTM213AC47MB1
EPIGALLOCATECHIN GALLATE STEARATESINACTIVE INGREDIENTMGB2NQG22C1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6621
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0E1
Hyaluronic AcidINACTIVE INGREDIENTS270N0TRQY1
LUTEININACTIVE INGREDIENTX72A60C9MT1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
Safflower OilINACTIVE INGREDIENT65UEH262IS1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54866-00254866-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHACTIB
WATER059QF0KO0RIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
CETYL ALCOHOL936JST6JCNIACT
STEARIC ACID4ELV7Z65APIACT
GLYCOL STEARATE0324G66D0EIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
Safflower Oil65UEH262ISIACT
Propylene Glycol6DC9Q167V3IACT
GlycerinPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALOE VERA LEAFZY81Z83H0XIACT
EPIGALLOCATECHIN GALLATE STEARATESMGB2NQG22CIACT
EPIGALLOCATECHIN GALLATE PALMITATESM213AC47MBIACT
EUCALYPTUS OIL2R04ONI662IACT
Hyaluronic AcidS270N0TRQYIACT
LUTEINX72A60C9MTIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
TROLAMINE9O3K93S3TKIACT

Source Document#

Source XML · Source PDF

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 5 · 257 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / OPHTHALMIC1.5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCAPSULE, DELAYED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, ORALLY DISINTEGRATING / ORAL9 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / TOPICAL3.27 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TRANSDERMAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3FILM, EXTENDED RELEASE / TRANSDERMAL58.13 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET / SUBLINGUAL1.23 mgExact identifier — unii candidate
21 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNEMULSION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKPOWDER / TOPICAL0.02 mg/mgExact identifier — unii candidate
22 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, DELAYED RELEASE / ORAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / VAGINAL200 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii candidate
21 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSPONGE / TOPICAL11 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCOL STEARATEGLYCOL STEARATE0324G66D0ESHAMPOO, SUSPENSION / TOPICAL5 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAMUSCULAR7459 mgExact identifier — unii candidate
81 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii candidate
26 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKDROPS / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii candidate
81 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 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
dea0cd6a-9743-4539-a694-c88cf3543525f86b5de9-8e44-4d06-890e-75f7e71c79e42014-03-07WarningsExact identifier
spl id: dea0cd6a-9743-4539-a694-c88cf3543525
spl set id: f86b5de9-8e44-4d06-890e-75f7e71c79e4

Reported adverse events (FAERS/openFDA)#

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