ANBESOL COLD SORE THERAPY

Manufacturer
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Effective date
2020-11-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:34:14

Label at a glance#

ProductANBESOL COLD SORE THERAPY
Active ingredientALLANTOIN, BENZOCAINE, CAMPHOR (SYNTHETIC), PETROLATUM
Label structure8 sections

Indications and uses

1. temporarily relieves pain associated with fever blisters and cold sores 2. relieves dryness and softens fever blisters and cold sores

Dosage and administration

1. to open tube, cut tip of the tube on score mark with scissors 2. adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily 3. children under 12 years of age: adult supervision should be given in the use of this product 4. children under 2 years of age: do not use

Storage and handling

store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Allantoin 1%

Benzocaine 20%

Camphor 3%

White petrolatum 64.9%

Purposes

OTC - PURPOSE SECTION

Skin protectant

Fever blister/cold sore treatment

Fever blister/cold sore treatment

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  1. temporarily relieves pain associated with fever blisters and cold sores
  2. relieves dryness and softens fever blisters and cold sores

Warnings

WARNINGS SECTION

METHEMOGLOBINEMIA WARNING

SPL UNCLASSIFIED SECTION

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  1. pale, gray, or blue colored skin (cyanosis)
  2. headache
  3. rapid heart rate
  4. shortness of breath
  5. dizziness or lightheadedness
  6. fatigue or lack of energy

SPL UNCLASSIFIED SECTION

For external use only

Allergy alert

SPL UNCLASSIFIED SECTION

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.

Do not use

OTC - DO NOT USE SECTION

  1. on deep or puncture wounds
  2. on animal bites
  3. on serious burns
  4. for teething
  5. in children under age 2

When using this product

OTC - WHEN USING SECTION

  1. avoid contact with the eyes
  2. do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  1. condition worsens
  2. symptoms persist for more than 7 days
  3. symptoms clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  1. to open tube, cut tip of the tube on score mark with scissors
  2. adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily
  3. children under 12 years of age: adult supervision should be given in the use of this product
  4. children under 2 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, benzyl alcohol, butylparaben, glyceryl monostearate, isocetyl stearate, menthol, methylparaben, mineral oil, propylparaben, sodium lauryl sulfate, vitamin E, white wax

Questions or comments?

OTC - QUESTIONS SECTION

Call weekdays 9AM to 5PM EST at 1-888-797-5638

PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ointment
WITH
Vitamin E
& Aloe

See new warnings information

Anbesol®
Fever Blister/Cold Sore Treatment

Cold Sore THERAPY

MAXIMUM
STRENGTH

DOCTOR
RECOMMENDED

Instant
Pain Relief

  1. Cold Sores and
    Fever Blisters
  2. Moisturizes While It
    Treats and Protects

NET WT 0.33 OZ (9 g)

Safety Sealed Tube:
Do Not Use if tube tip is cut prior to opening.

Principal Display Panel - 9 g Tube Blister Pack Label
Principal Display Panel - 9 g Tube Blister Pack Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1006096allantoin 1 % / benzocaine 20 % / camphor 3 % / petrolatum 64.9 % Topical OintmentPSN6
1052620Anbesol Cold Sore Therapy 1 % / 20 % / 3 % / 64.9 % Topical OintmentPSN6
1052620allantoin 0.01 MG/MG / benzocaine 0.2 MG/MG / camphor 0.03 MG/MG / petrolatum 0.649 MG/MG Topical Ointment [Anbesol Cold Sore Therapy]SBD6
1006096allantoin 0.01 MG/MG / benzocaine 0.2 MG/MG / camphor 0.03 MG/MG / petrolatum 0.649 MG/MG Topical OintmentSCD6
1006096allantoin 1 % / benzocaine 20 % / camphor 3 % / petrolatum, white 64.9 % Topical OintmentSY6
1052620Anbesol Cold Sore Therapy (allantoin 1 % / benzocaine 20 % / camphor 3 % / petrolatum, white 64.9 % ) Topical OintmentSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0246-252022-01-28C16284748780-1d6a99b39-999d-a426-e053-dadaa90af4c2Drug Facts
0573-0246-262022-01-28C16284748780-1d6a99b39-999d-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0246-25ANBESOL COLD SORE THERAPY1 in 1 BLISTER PACKOINTMENT16
0573-0246-25ANBESOL COLD SORE THERAPY9 g in 1 TUBEOINTMENT96
0573-0246-26ANBESOL COLD SORE THERAPY9 g in 1 TUBEOINTMENT96
0573-0246-26ANBESOL COLD SORE THERAPY1 in 1 BLISTER PACKOINTMENT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0246ANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]6Legacy NDC, 4 package rows20201126_25bcfa70-64f9-18d6-51b0-83282c2f84be.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0246-25GM - Gram0573-0246b7119f84-1b88-4cb3-aa5b-59c9b4548ee412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
allantoinACTIVE INGREDIENT344S277G0Z3
benzocaineACTIVE INGREDIENTU3RSY48JW53
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET3
petrolatumACTIVE INGREDIENT4T6H12BN9U3
allantoinACTIVE MOIETY344S277G0Z3
benzocaineACTIVE MOIETYU3RSY48JW53
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET3
petrolatumACTIVE MOIETY4T6H12BN9U3
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X3
alpha-tocopherolINACTIVE INGREDIENTH4N855PNZ13
benzyl alcoholINACTIVE INGREDIENTLKG8494WBH3
butylparabenINACTIVE INGREDIENT3QPI1U3FV83
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE43
mentholINACTIVE INGREDIENTL7T10EIP3A3
methylparabenINACTIVE INGREDIENTA2I8C7HI9T3
mineral oilINACTIVE INGREDIENTT5L8T28FGP3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH3
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141J3
white waxINACTIVE INGREDIENT7G1J5DA97F3

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-02460573-0246-25, 0573-0246-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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 6 · 354 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
propylparabenPROPYLPARABENZ8IX2SC1OHGEL / VAGINAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCREAM / VAGINAL3 mgExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCONCENTRATE / ORAL12 mgExact identifier — unii candidate
79 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JCAPSULE, EXTENDED RELEASE / ORAL166 mgExact identifier — unii candidate
42 equally ranked IID candidates
alpha-tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii candidate
68 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JPOWDER / VAGINAL3 mgExact identifier — unii candidate
42 equally ranked IID candidates
alpha-tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TELIXIR / ORAL800 mgExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TJELLY / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TDROPS / AURICULAR (OTIC)0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ASOLUTION / DENTALNAExact identifier — unii candidate
24 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
42 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHSOLUTION / TOPICAL2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCAPSULE, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
white waxWHITE WAX7G1J5DA97FTABLET / ORAL5 mgExact identifier — unii candidate
15 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JGRANULE / ORAL12 mgExact identifier — unii candidate
42 equally ranked IID candidates
mentholMENTHOLL7T10EIP3AAEROSOL, METERED / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JSPRAY / TOPICAL7 mgExact identifier — unii candidate
42 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
79 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
42 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRADERMAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
50 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ATABLET, ORALLY DISINTEGRATING / ORAL14 mgExact identifier — unii candidate
24 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAMUSCULAR6 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii candidate
50 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHAEROSOL, FOAM / TOPICAL0.04 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ASOLUTION, CONCENTRATE / ORAL0.5 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SUBCUTANEOUS22 mgExact identifier — unii candidate
79 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSYSTEM / TOPICAL21 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSPRAY / TOPICAL0.8 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ADROPS / NASAL40.32 mgExact identifier — unii candidate
24 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii candidate
68 equally ranked IID candidates
mentholMENTHOLL7T10EIP3APASTE, DENTIFRICE / DENTAL4.7 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHCREAM / VAGINAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INFILTRATION0.35 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHTABLET, EXTENDED RELEASE / ORAL0.12 mgExact identifier — unii candidate
68 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
white waxWHITE WAX7G1J5DA97FTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
15 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4GRANULE, FOR SUSPENSION / ORAL4 mgExact identifier — unii candidate
21 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION / INTRALESIONAL23 mgExact identifier — unii candidate
50 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
7ace5d51-e912-4a2b-8f40-a861ffc778b425bcfa70-64f9-18d6-51b0-83282c2f84be2020-11-25WarningsExact identifier
spl id: 7ace5d51-e912-4a2b-8f40-a861ffc778b4
spl set id: 25bcfa70-64f9-18d6-51b0-83282c2f84be

Reported adverse events (FAERS/openFDA)#

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