Docosanol Cream, 10%

Manufacturer
KLM Laboratories Private Limited
Effective date
2026-10-01
Label type
Human OTC Drug Label
Version
12
Source
daily-update
Hydrated at
2026-10-06 02:04:02

Label at a glance#

ProductDocosanol
Active ingredientDOCOSANOL
Label structure15 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 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

Storage and handling

store at 20°-25°C (68°-77°F). do not freeze.

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.

Syptoms 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 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 infection.

Stop use and ask 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 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

STORAGE AND HANDLING SECTION

  • store at 20°-25°C (68°-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?

SPL UNCLASSIFIED SECTION

call toll-free 1-866-547-5097 from Monday to Friday between 9:00 am to 5.00 pm

Distributed by:
One2Zee LLC,
61 Bay Hill Blvd,
Monroe Township,
NJ 08831
Active ingredient made in India

Additional information

SPL UNCLASSIFIED SECTION

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

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

Thank you for purchasingDocosanol Cream, 10%.We hope that since Docosanol Cream shortens the healing time of cold sores, it helps you look and feel better faster. Please follow insert 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, 10%, the more effective the medicine will be. So for best results, use Docosanol Cream, 10% 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:

SPL UNCLASSIFIED SECTION

For Pump Bottle
How to use your Docosanol Cream, 10% Pump
- For Adults and children 12 years and over can use 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.

- 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%.
Press Pump completely about 6-8 times to get first dose.


pump-step
pump-step

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 6-8 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.

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 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%.


Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For Tube - Carton Label

NDC 84725-001-01

KLM

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*

NET WT 2 g (0.07oz)

tube-carttube-cart

For Pump Bottle - Carton Label

NDC 84725- 001-02

KLM

Docosanol Cream, 10%

COLD SORE/FEVER BLISTER TREATMENT

Shortens Healing Time and Duration of Symptoms

‣Tingling ‣Pain ‣Burning ‣Itching

Convenient PORTABLE Pump

The only FDA Approved Medicine to SHORTEN HEALING TIME*

NET WT 2 g (0.07oz)

pump-cart
pump-cart

For Twin Pack - Tube Carton Label

NDC 84725- 001-09

KLM

Docosanol Cream, 10%

COLD SORE/FEVER BLISTER TREATMENT

Shortens Healing Time and Duration of Symptoms

‣Tingling ‣Pain ‣Burning ‣Itching

Twin Pack

The only FDA Approved Medicine to SHORTEN HEALING TIME*

2 TUBES OF 2 g (0.07 oz)

TOTAL NET WT 4 g (0.14 oz)

twin-pack-carttwin-pack-cart

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84725-00184725-001-01, 84725-001-02, 84725-001-09

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
102026-09-08daily-update2026-09-11 03:02:47
32026-08-18daily-update2026-09-08 02:02:28
22024-09-25daily-update2026-08-04 03:32:57

Orange Book application contexts#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
2026-09-14 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#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DocosanolDOCOSANOLKLM Laboratories Private Limited5783edbf-2ce6-4b7e-8df3-2e421c63d0e82026-09-08WarningsExact identifier
ndc (package): 84725-001-02
ndc (package): 84725-001-01
ndc (product): 84725-001
ndc11 (package): 84725000101
ndc11 (package): 84725000102
spl set id: 5783edbf-2ce6-4b7e-8df3-2e421c63d0e8

Reported adverse events (FAERS/openFDA)#

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