SPL v4
SPL
SPL Set ID 16ae0976-2940-27ae-e063-6394a90a62e8
Route
TOPICAL
Published
Effective Date 2025-12-11
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Docosanol (100 mg)
Inactive Ingredients
Benzyl Alcohol Light Mineral Oil Propylene Glycol Water Sucrose Distearate Sucrose Stearate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2024-06-26

Description

Active ingredient    Docosanol 10%

Purpose

Cold sore/fever blister treatment


Medication Information

Purpose

Cold sore/fever blister treatment

Description

Active ingredient    Docosanol 10%

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

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

Directions

• 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

• store at 20° to 25°C (68° to 77°F).

• do not freeze



Do Not Use

• If you are allergic to any ingredient in this product

Drug Facts

Active ingredient   

Docosanol 10%

Inactive Ingredients

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

Questions or comments?

call 1-800-632-6900

Additional Information

*Contains the only non-prescription cold sore  medicine approved by the FDA to shorten healing time and duration of symptoms.

Retain insert for full product uses, directions and warnings.



DISTRIBUTED BY

THE KROGER CO., CINCINNATI, OHIO 45202

MADE IN INDIA

‡OUR PHARMACIST RECOMMENDED



Code: TS/DRUGS/58039/2020

Thank you for purchasing Docosanol Cream. 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, 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 is different from other over-the-counter cold sore products. Only docosanol cream 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:



How is docosanol cream different from the over-the-counter cold sore remedies I have already been using?



Docosanol cream is the only FDA approved non-prescription cold sore medicine that can actually shorten healing time and the duration of symptoms. The sooner you start using docosanol cream, the sooner you can begin healing your cold sore.

Who can use docosanol cream?

Adults and children 12 years and over can use docosanol cream.

How often can I apply docosanol cream?

Docosanol cream 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?

Yes, cosmetics such as lipstick may be applied over docosanol cream. 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.



For more information:



Call us at 1-800-632-6900

When Using This Product

• 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 A Doctor If

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

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Package Label Principal Display Panel  tube Label 10% (2 G Tube)

NDC 30142-286-02

Kroger®

health

Docosanol Cream 10%

COLD SORE / FEVER

BLISTER TREATMENT

NET WT 0.07 0Z (2g)

For Topical Use Only





Package Label Principal Display Panel Tube Square Blister Card Label 10% (2 G Tube)

NDC 30142-286-02



Kroger®

health



COMPARE TO THE ACTIVE INGREDIENT

IN ABREVA® COLD SCORE CREAM



Docosanol Cream 10%

Cold Sore/

Fever Blister

Treatment


Non-Prescription

Medicine to

Shorten

Healing Time*



COLD SORE TREATMENT

FOR TOPICAL USE ONLY



NET WT


0.07 oz (2 g)



Package Label Principal Display Panel Tube clamshell Blister Card label 10% (2 G Tube)

NDC 30142-286-04



Kroger®

health



COMPARE TO THE ACTIVE INGREDIENT

IN ABREVA® COLD SCORE CREAM



Docosanol Cream 10%

Cold Sore/

Fever Blister

Treatment                                      TWIN

Non-Prescription                             PACK

Medicine to

Shorten

Healing Time*



COLD SORE

TREATMENT

FOR TOPICAL

USE ONLY



NET WT 0.14 OZ

(4 g) (2 TUBES,

0.07 OZ

[2 g] EACH)






Structured Label Content

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

Cold sore/fever blister treatment

Warnings

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

Directions

• 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

• store at 20° to 25°C (68° to 77°F).

• do not freeze



Do Not Use (Do not use)

• If you are allergic to any ingredient in this product

Drug Facts

Active ingredient   

Docosanol 10%

Inactive Ingredients (Inactive ingredients)

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

Questions or comments?

call 1-800-632-6900

Additional Information (Additional information)

*Contains the only non-prescription cold sore  medicine approved by the FDA to shorten healing time and duration of symptoms.

Retain insert for full product uses, directions and warnings.



DISTRIBUTED BY

THE KROGER CO., CINCINNATI, OHIO 45202

MADE IN INDIA

‡OUR PHARMACIST RECOMMENDED



Code: TS/DRUGS/58039/2020

Thank you for purchasing Docosanol Cream. 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, 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 is different from other over-the-counter cold sore products. Only docosanol cream 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:



How is docosanol cream different from the over-the-counter cold sore remedies I have already been using?



Docosanol cream is the only FDA approved non-prescription cold sore medicine that can actually shorten healing time and the duration of symptoms. The sooner you start using docosanol cream, the sooner you can begin healing your cold sore.

Who can use docosanol cream?

Adults and children 12 years and over can use docosanol cream.

How often can I apply docosanol cream?

Docosanol cream 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?

Yes, cosmetics such as lipstick may be applied over docosanol cream. 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.



For more information:



Call us at 1-800-632-6900

When Using This Product (When using this product)

• 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 A Doctor If (Stop use and ask a doctor if)

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

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Package Label Principal Display Panel  tube Label 10% (2 G Tube) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Label 10% (2 g Tube))

NDC 30142-286-02

Kroger®

health

Docosanol Cream 10%

COLD SORE / FEVER

BLISTER TREATMENT

NET WT 0.07 0Z (2g)

For Topical Use Only





Package Label Principal Display Panel Tube Square Blister Card Label 10% (2 G Tube) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Square Blister Card Label 10% (2 g Tube))

NDC 30142-286-02



Kroger®

health



COMPARE TO THE ACTIVE INGREDIENT

IN ABREVA® COLD SCORE CREAM



Docosanol Cream 10%

Cold Sore/

Fever Blister

Treatment


Non-Prescription

Medicine to

Shorten

Healing Time*



COLD SORE TREATMENT

FOR TOPICAL USE ONLY



NET WT


0.07 oz (2 g)



Package Label Principal Display Panel Tube clamshell Blister Card label 10% (2 G Tube) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Clamshell Blister Card label 10% (2 g Tube))

NDC 30142-286-04



Kroger®

health



COMPARE TO THE ACTIVE INGREDIENT

IN ABREVA® COLD SCORE CREAM



Docosanol Cream 10%

Cold Sore/

Fever Blister

Treatment                                      TWIN

Non-Prescription                             PACK

Medicine to

Shorten

Healing Time*



COLD SORE

TREATMENT

FOR TOPICAL

USE ONLY



NET WT 0.14 OZ

(4 g) (2 TUBES,

0.07 OZ

[2 g] EACH)






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