Docosanol Cream, 10%

Manufacturer
United Natural Foods, Inc. dba UNFI
Effective date
2024-11-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:49:10

Label at a glance#

ProductDocosanol
Active ingredientDOCOSANOL
Label structure14 sections

Indications and uses

treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: • tingling, pain, burning, and/or itching

Dosage and administration

adults and children 12 years or over: wash hands before and after applying cream apply to affected area on the face or lips at the first sign of cold sore/fever blister (tingle). early treatment ensures the best results rub in gently but completely use 5 times a day until healed children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

 Docosanol  10%

Purpose

OTC - PURPOSE SECTION

Cold sore/fever blister treatment

Uses

INDICATIONS & USAGE SECTION

  • treats cold sores/fever blisters on the face or lips
  • shortens healing time and duration of symptoms:
    • tingling, pain, burning, and/or itching

Warnings

WARNINGS SECTION

Allergy Alert

This product may cause a severe allergic reaction. Symptoms may include:

  • hives
  • facial swelling
  • wheezing/difficulty breathing
  • shock
  • rash

If an allergic reaction occurs, stop use and seek medical help right away.

For external use only

Do not use

OTC - DO NOT USE SECTION

  •  if you are allergic to any ingredient in this product

When using this product

OTC - WHEN USING SECTION

  • apply only to the affected areas
  • do not use in or near the eyes
  • avoid applying directly inside your mouth
  • do not share this product with anyone. This may spread the infection.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • your cold sore gets worse or the cold sore is not healed within 10 days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

 If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years or over:
    • wash hands before and after applying cream
    • apply to affected area on the face or lips at the first sign of cold sore/fever blister (tingle).
    • early treatment ensures the best results
    • rub in gently but completely
    • use 5 times a day until healed
  • children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at 20° to 25°C (68° to 77°F)
  • do not freeze

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-855-423-2630

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to active ingredient in Abreva®†

Docosanol Cream 10%

Cold sore/fever blister treatment

  • Only FDA approved medicine to shorten healing time*
  • Cold sore treatment

For topical use only

NET WT 2g (0.07 OZ)

*Docosanol Cream, 10% contains the only OTC medicine approved by the FDA to shorten healing time and duration of symptoms.

†This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Abreva®.

RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTION AND WARNINGS.

DISTRIBUTED BY: UNFI

PROVIDENCE, RI 02908

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EQUALINE Cold Sore Fever Blister Treatment
EQUALINE Cold Sore Fever Blister Treatment

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83455-11283455-112-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
0361d71e-3d8e-4e1d-939b-226d2f6b2f4a1058df55-752c-4554-bedb-d36a5cdecd1a2025-01-24WarningsExact identifier
spl set id: 1058df55-752c-4554-bedb-d36a5cdecd1a

Reported adverse events (FAERS/openFDA)#

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