SPL v2
SPL
SPL Set ID 9f361f24-a0a1-4e43-a158-8c830c9adca7
Route
TOPICAL
Published
Effective Date 2024-08-16
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 2024-03-01

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 toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Additional Information

*Contains the only non-prescription cold sore  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:                                            

AUROHEALTH LLC,                                                         

279 Princeton-Hightstown Road,

East Windsor, NJ 08520                                              

Made in India

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.



How to use your docosanol cream Pump (for pump pack)

- For Adults and Children 12 years and older

- 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.



- If you wish, you can apply cosmetics such as lipstick 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.



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.



For more information:



Call us at 1-855-274-4122

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 Pump Label 10% (2 G Pump)

AUROHEALTH

NDC 58602-019-14

Docosanol

Cream 10%

Cold Sore/

Fever Blister

Treatment

For Topical Use Only


NET WT 2 g

(0.07 oz)





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

Docosanol Cream 10%

Cold Sore/Fever Blister Treatment

For Topical Use Only

NET WT 2 g (0.07 oz)



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

AUROHEALTH

#Compare to the active

ingredient in Abreva®

NDC 58602-019-15

Docosanol Cream 10%

Cold Sore/Fever Blister Treatment


Non-Prescription Medicine to Shorten Healing Time*

Portable

Convenient

Pump

Cold Sore Treatment

For Topical Use Only


NET WT 2 g (0.07 oz)



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

AUROHEALTH

#Compare to the active

ingredient in Abreva®

NDC 58602-019-08

Docosanol Cream 10%

Cold Sore/Fever Blister Treatment


Non-Prescription Medicine to Shorten Healing Time*

Cold Sore Treatment

For Topical Use Only


NET WT 2 g (0.07 oz)



Package Label Principal Display Panel Pump Clamshell Blister Card label 10% (2 G Pump)

AUROHEALTH

#Compare to the active

Ingredient in Abreva®

NDC 58602-019-16

Docosanol Cream 10%

Cold Sore/Fever Blister Treatment


Non-Prescription Medicine to Shorten Healing Time*

Portable

Convenient

Pump

Cold Sore Treatment

For Topical Use Only


Read Inside fold out

for full details


NET WT

2 g (0.07 oz)



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

AUROHEALTH

#Compare to the active

Ingredient in Abreva®

NDC 58602-019-24

Docosanol Cream 10%

Cold Sore/Fever Blister Treatment


Non-Prescription Medicine to Shorten Healing Time*

Cold Sore Treatment

For Topical Use Only

NET WT 2 g (0.07 oz)




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 toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

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 this insert for full product uses, directions and warnings.

Distributed by:                                            

AUROHEALTH LLC,                                                         

279 Princeton-Hightstown Road,

East Windsor, NJ 08520                                              

Made in India

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.



How to use your docosanol cream Pump (for pump pack)

- For Adults and Children 12 years and older

- 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.



- If you wish, you can apply cosmetics such as lipstick 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.



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.



For more information:



Call us at 1-855-274-4122

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 Pump Label 10% (2 G Pump) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Pump Label 10% (2 g Pump))

AUROHEALTH

NDC 58602-019-14

Docosanol

Cream 10%

Cold Sore/

Fever Blister

Treatment

For Topical Use Only


NET WT 2 g

(0.07 oz)





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

Docosanol Cream 10%

Cold Sore/Fever Blister Treatment

For Topical Use Only

NET WT 2 g (0.07 oz)



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

AUROHEALTH

#Compare to the active

ingredient in Abreva®

NDC 58602-019-15

Docosanol Cream 10%

Cold Sore/Fever Blister Treatment


Non-Prescription Medicine to Shorten Healing Time*

Portable

Convenient

Pump

Cold Sore Treatment

For Topical Use Only


NET WT 2 g (0.07 oz)



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))

AUROHEALTH

#Compare to the active

ingredient in Abreva®

NDC 58602-019-08

Docosanol Cream 10%

Cold Sore/Fever Blister Treatment


Non-Prescription Medicine to Shorten Healing Time*

Cold Sore Treatment

For Topical Use Only


NET WT 2 g (0.07 oz)



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

AUROHEALTH

#Compare to the active

Ingredient in Abreva®

NDC 58602-019-16

Docosanol Cream 10%

Cold Sore/Fever Blister Treatment


Non-Prescription Medicine to Shorten Healing Time*

Portable

Convenient

Pump

Cold Sore Treatment

For Topical Use Only


Read Inside fold out

for full details


NET WT

2 g (0.07 oz)



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))

AUROHEALTH

#Compare to the active

Ingredient in Abreva®

NDC 58602-019-24

Docosanol Cream 10%

Cold Sore/Fever Blister Treatment


Non-Prescription Medicine to Shorten Healing Time*

Cold Sore Treatment

For Topical Use Only

NET WT 2 g (0.07 oz)




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