Docosanol Cream, 10%

Manufacturer
Rite Aid Corporation
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-06-03 17:46:55

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 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Abreva®†

COLD SORE/FEVER BLISTER TREATMENT

DOCOSANOL CREAM, 10%

Only FDA approved medicine to shorten healing time.*

Cold sore treatment

NET WT OZ (g)

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

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

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

DISTRIBUTED BY: RITE AID,

200 NEWBERRY COMMONS

ETTERS, PA 17319

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RITE AID Cold Sore Fever Blister Treatment
RITE AID Cold Sore Fever Blister Treatment

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130011822011280GTIN-13: 0011822011280
EAN-13: 0011822011280
GTIN-12: 011822011280
UPC-A: 011822011280
GTIN storage (14 digits): 00011822011280
docosanol-10-percent-cream-ene-0-07-delisted-1.jpg

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-345111822-3451-7

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-10-27monthly-update2026-06-03 17:38:29
22024-03-12full-release2026-06-01 00:09:42

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
46847e99-e771-46b2-81da-750be147a0d9aa310b20-501e-4821-834e-4abcd02a81fa2025-12-29WarningsExact identifier
spl id: 46847e99-e771-46b2-81da-750be147a0d9
spl set id: aa310b20-501e-4821-834e-4abcd02a81fa

Reported adverse events (FAERS/openFDA)#

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