FDA.reportPublic FDA data

eos Medicated Pain Relief Cold Sore Treatment

Manufacturer
eos Products LLC
Effective date
2024-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:07:24

Label at a glance#

Producteos Medicated Pain Relief Cold Sore Treatment
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC), ALLANTOIN
Label structure11 sections

Indications and uses

For the temporary relief of pain associated with fever blisters and cold sores. Helps prevent and protect and relieve chapped lips.

Dosage and administration

Adults and children 2 years of age and older: Apply to lips not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE SECTION

Active Ingredients Purpose

Allantoin 0.50% Fever blister/cold sore treatment

Camphor 0.50% Fever blister/cold sore treatment

Menthol 0.625% Fever blister/cold sore treatment

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain associated with fever blisters and cold sores.
  • Helps prevent and protect and relieve chapped lips.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product • Do not get into eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if • condition worsens •symptoms last more than 7 days or 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

  • Adults and children 2 years of age and older: Apply to lips not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Bis-Diglyceryl Polyacyladipate-2, Jojoba Esters, Hydrogenated Polyisobutene, Ricinus Communis (Castor) Seed Oil, Dimer Dilinoleyl Dimer Dilinoleate, Diisostearyl Malate, Octyldodecanol, Nylon-12, Beeswax/Cire d'abeille, Helianthus Annuus (Sunflower) Seed Wax, Flavor/Aroma, Silica Dimethyl Silylate, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Polyglycerin-3, Acacia Decurrens Flower Wax, Stearalkonium Hectorite, Stevia Rebaudiana Leaf/Stem Extract, Helianthus Annuus (Sunflower) Seed Oil, Propylene Carbonate, Limonene, Mentha Piperita (Peppermint) Leaf Extract, Linalool, Tocopherol, Citric Acid.

Questions or comments?

OTC - QUESTIONS SECTION

(866)-547-4367

Principal Display Panel 0.35 fl. oz. (10mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

eos Medicated Pain Relief Cold Sore Treatment 0.35 fl. oz. (10mL) Outer LabelOuter Label Inner LabelInner Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70170-0023EOS MEDICATED PAIN RELIEF COLD SORE TREATMENT (ALLANTOIN, CAMPHOR, MENTHOL) OINTMENT [EOS PRODUCTS LLC]1Unmatched20240327_132a37b9-3ab1-d0e8-e063-6294a90a043b.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70170-002370170-0023-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
FRAGRANCE PEPPERMINT ORC2000647UHZ8T78D8BIACT
OCTYLDODECANOL461N1O614YIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
COCOA BUTTER512OYT1CRRIACT
SUNFLOWER OIL3W1JG795YIIACT
ACACIA DECURRENS FLOWER WAXAU6XZE9IY9IACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
POLYGLYCERIN-34A0NCJ6RD6IACT
PROPYLENE CARBONATE8D08K3S51EIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
NYLON-12446U8J075BIACT
CASTOR OILD5340Y2I9GIACT
YELLOW WAX2ZA36H0S2VIACT
LINALOOL, (+/-)-D81QY6I88EIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
SHEA BUTTERK49155WL9YIACT
MENTHA PIPERITA LEAFA389O33LX6IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LIMONENE, (+)-GFD7C86Q1WIACT
DIMER DILINOLEYL DIMER DILINOLEATE0E2D5DBT7MIACT
TOCOPHEROLR0ZB2556P8IACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
ALLANTOIN344S277G0ZACTIB

Source Document#

Source XML

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
42b3f6d8-b90f-26a9-e063-6394a90a7ea1132a37b9-3ab1-d0e8-e063-6294a90a043b2025-11-03WarningsExact identifier
spl set id: 132a37b9-3ab1-d0e8-e063-6294a90a043b

Reported adverse events (FAERS/openFDA)#

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