Docosanol Cream, 10%

Manufacturer
BIONPHARMA INC. | KLM Laboratories Private Limited
Effective date
2026-10-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-10-27 02:03:59

Label at a glance#

ProductDocosanol
Active ingredientDOCOSANOL
Label structure17 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#

SPL UNCLASSIFIED SECTION

Drug Facts

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 1-866-547-5097

(Mon-Fri 9AM-5PM EST)

SPL UNCLASSIFIED SECTION

Retain this carton for full product uses, directions and warnings.

If you are not completely satisfied, save receipt and remaining product, and call us at 1-866-547-5097

Mfg. License No. : G/25/2627

Distributed by:

Bionpharma Inc.

Princeton, NJ 08540

MADE IN INDIA

For Tube (twin pack):

NDC 69452-550-12

L0001307 R0726

For Pump:

NDC 69452-550-61

L0001306 R0726

SPL UNCLASSIFIED SECTION

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

Thank you for purchasing Docosanol Cream, 10%

We hope that since Docosanol Cream has been demonstrated to shorten the healing time of cold sores, it helps you look and feel better faster. Please follow carton directions for proper use and refer to the information below.

You are not alone

An estimated one-in-five Americans is affected by cold sores each year. Most people who experience them get two to three cold sore outbreaks each year. Just before and during an outbreak, the cold sore infection can be easily passed on to others. It is especially important to be aware of early warning signs that a cold sore is coming, and to be sure to avoid close physical contact when you have one.

Getting to the Root of the Problem

A blister, or cluster of blisters around your mouth, is caused by the cold sore virus. After the cold sore has healed, the virus stays dormant in your body but can be reactivated by everyday triggers like stress, sunlight, extreme hot or cold weather, colds and flu, lack of sleep, or menstruation.

The Sooner, the Better

A typical cold sore outbreak can last as long as seven to ten days. The sooner you begin using docosanol cream, the more effective the medicine will be. So for best results, use docosanol cream at the very start of the cold sore - when you feel the first sign of the tingle, redness, bump or itch.

Docosanol Cream, 10% is different from other over-the-counter cold sore products. Only docosanol cream, 10% contains 10% docosanol, which helps to shorten the healing time of cold sores and the duration of symptoms including tingling, pain, itching and burning.

Frequently Asked Questions:

For Tube:
Who can use Docosanol Cream, 10%?

Adults and children 12 years and over can use Docosanol Cream, 10%.

How often can I apply Docosanol Cream, 10%?

Docosanol Cream, 10% should be used five times a day until the cold sore is healed.

Apply it directly to the cold sore at the first sign of a tingle, redness, bump or itch for best results.

Can I apply cosmetics on top of Docosanol Cream, 10%?

Yes, cosmetics such as lipstick may be applied overDocosanol Cream, 10%. However, use a separate applicator, like a cotton swab, to apply cosmetics over an unhealed cold sore to avoid spreading the infection. For best results, remove any cosmetics prior to applying Docosanol Cream, 10%.

For Pump:

How to use your Docosanol Cream, 10% Pump

- For Adults and Children 12 years and over
- Docosanol cream, 10% should be used five times a day until the cold sore is healed. Apply it directly to the cold sore at the first sign of a tingle, redness, bump or itch for best results.
- If you wish, you can apply cosmetics such as lipstick over Docosanol Cream, 10%. However, use a separate applicator, like a cotton swab, to apply cosmetics over an unhealed cold sore to avoid spreading the infection. For best results, remove any cosmetics prior to applying Docosanol Cream, 10%.

STEP 1 – Wash your hands before and after treating the cold sore.
STEP 2 – Remove cap and press pump firmly. When first used, expect to press pump completely about 6 to 8 times before obtaining first dose.
STEP 3 – Rub in gently but completely 5 times a day until healed for maximum of 10 days.
STEP 4 – Place cap back on pump after each use.

image1image1

For more information: Call us at 1-866-547-5097

Tube carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

a+ health TM

docosanol cream, 10%

cold sore/fever blister treatment

shortens healing time and duration of symptoms

• tingling • pain • burning • itching

the only FDA

approved medicine

to shorten

healing time*

2 tubes of 2 g (0.07 oz)

total net wt 4g (0.14oz)

TWIN

PACK

tube-cartontube-carton

Pump carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

a+ health TM

docosanol cream, 10%

cold sore/fever blister treatment

shortens healing time and duration of symptoms

• tingling • pain • burning • itching

the only FDA

approved medicine

to shorten

healing time*

convinient

PORTABLE

pump

net wt 2g (0.07oz)

pump-cartonpump-carton

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
69452-55069452-550-02, 69452-550-61

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
32026-10-20daily-update2026-10-23 01:02:03
22026-10-13daily-update2026-10-16 01:02:02
12026-10-09daily-update2026-10-13 04:05:05

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220017-001DOCOSANOLDOCOSANOL10%CREAM / TOPICAL2026-07-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A220017-001DOCOSANOL10%CREAM / TOPICAL2026-07-31c2088c7a36db…
2026-09-14 22:38:342026-08A220017-001DOCOSANOL10%CREAM / TOPICAL2026-07-3184e616aacf4f…
2026-08-18 06:07:402026-07A220017-001DOCOSANOL10%CREAM / TOPICAL2026-07-31caaa826d4ba7…

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 4 · 68 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Sore Fever Blister TreatmentDOCOSANOLWalgreensac3280b7-00aa-46cd-84e2-0a11992028ab2026-08-06WarningsName fallback
generic name: DOCOSANOL
DocosanolDOCOSANOLYYBA Corp289e5003-7d08-c141-e063-6394a90abca32026-07-20WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLSportpharm LLCe3e6c0b0-399f-41e4-9df9-109ee29179952026-07-12WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLThe Kroger Co.42b46e02-4d1f-411e-be9e-227f62ba5a862026-06-23WarningsName fallback
generic name: DOCOSANOL
DOCOSANOLDOCOSANOLAurohealth LLC9f361f24-a0a1-4e43-a158-8c830c9adca72026-06-10WarningsName fallback
brand name: DOCOSANOL
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLWALMART INC. (see also Equate)f283ffd8-860a-4e97-8e22-94b907f75c8d2026-04-29WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLP & L Development, LLCe88e49b9-c292-48c5-b19e-630ffa6447e72026-04-02WarningsName fallback
generic name: DOCOSANOL
AMAZON BASICS DOCOSANOLDOCOSANOLAmazon.com Services LLC3c28a462-c6d6-70ba-e063-6394a90ae8f32026-03-18WarningsName fallback
generic name: DOCOSANOL
DOCOSANOLDOCOSANOLCVS Pharmacy, Inc.336b515c-5e7b-4ece-a94f-f8d8e9ce6a7b2026-03-13WarningsName fallback
brand name: DOCOSANOL
generic name: DOCOSANOL
DocosanolDOCOSANOLWALMART INC. (see also Equate)45cfa88b-8146-4349-99cc-beec704557092026-02-18WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLTARGET Corporationf68bd51a-9166-47a1-81f7-e379a93ab8232026-01-22WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLWalgreensa578c749-4264-4d5c-9357-ed482a04fb8b2026-01-15WarningsName fallback
generic name: DOCOSANOL
Cold Sore TreatmentDOCOSANOLP & L Development, LLC53cd18dc-bece-473e-a116-df6c88fe6fe72025-12-29WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLTopco Associates73348ce7-5b08-49ad-ba59-6f54887f819b2025-12-29WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLWalgreens73178cbc-21f8-4fc1-8d31-50601f10dbd42025-12-29WarningsName fallback
generic name: DOCOSANOL
DocosanolDOCOSANOLCare One (Retail Business Services, LLC.)9f31b742-4170-4219-80e3-2a5a71b3483e2025-12-29WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLSafeway, Inc.85bfd33e-9404-4483-b76c-0ee519aad7312025-12-29WarningsName fallback
generic name: DOCOSANOL
DocosanolDOCOSANOLWALMART INC. (see also Equate)e06fd4cf-cd92-4cae-94b7-abab95e97ebd2025-12-29WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLFSA Store Inc. (Caring Mills)fe67f56e-4c35-40cb-8a75-174a873f29002025-12-29WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever BlisterDOCOSANOLH E B71b2bb18-4a48-42c2-b03a-dccf581a0d972025-12-29WarningsName fallback
generic name: DOCOSANOL

Reported adverse events (FAERS/openFDA)#

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