Docosanol 10% Cream

Docosanol 10% Cream
SPL v2
SPL
SPL Set ID 5b3137d3-c186-4c5d-89d2-ec5d1c3da8cd
Route
TOPICAL
Published
Effective Date 2025-09-08
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 2022-10-10

Description

Docosanol 10%

Purpose

Cold sore/fever blister treatment


Medication Information

Purpose

Cold sore/fever blister treatment

Description

Docosanol 10%

Use(s)
  • treats cold sores/fever blisters on the face or lips
  • shortens healing time and duration of symptoms:
  •  tingling, pain, burning, and/or itching
Storage
  • store at 20°-25°C (68°-77°F)

do not freeze

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%.



Warnings

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

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

Do Not Use
  • if you are allergic to any ingredient in 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.
For Pump Bottle

How to use your Docosanol Cream, 10% Pump



- 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.



 

 

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.

Active Ingredient(s)

Docosanol 10%

Inactive Ingredients

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

Questions Or Comments?

call toll-free 1-833-285-4151 from Monday to Friday between 9 am to 6.30 pm

Manufactured by:

Encube Ethicals Private Limited

Plot No. C1,Madkaim Industrial Estate, Madkaim,

Post: Mardol, Ponda, Goa – 403 404, India

Distributed by:

Encube Ethicals, Inc.

200 Meredith Avenue, Suite 101A

Durham, NC 27713, USA

Thank you for purchasing Docosanol 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.



Principal Display Panel

For Pump Bottle - Carton Label

NDC 21922-023-17

DOCOSANOL 10% CREAM

Cold Sore/Fever Blister Treatment

Only FDA Approved to Shorten Healing Time*

Cold Sore Treatment

NET WT

2g (0.07oz)                                           































For Pump Bottle - Bottle Label

NDC 21922-023-17

DOCOSANOL 10% CREAM

Cold Sore/Fever Blister Treatment

Only FDA Approved to Shorten Healing Time*

Cold Sore Treatment

NET WT

2g (0.07oz)   









For Tube - Carton

NDC 21922-023-18

DOCOSANOL 10% CREAM

Cold Sore/Fever Blister Treatment

Only FDA Approved to Shorten Healing Time*

Cold Sore Treatment

NET WT

2g (0.07 oz) 

 





























For Tube

NDC 21922-023-18

DOCOSANOL 10% CREAM

Cold Sore/Fever Blister Treatment

Only FDA Approved to Shorten Healing Time*

Cold Sore Treatment

NET WT

2g (0.07 oz) 



 

 

 

Stop Use and Ask 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 right away.


Structured Label Content

Use(s) (USE(S))
  • treats cold sores/fever blisters on the face or lips
  • shortens healing time and duration of symptoms:
  •  tingling, pain, burning, and/or itching
Purpose (PURPOSE)

Cold sore/fever blister treatment

Storage (STORAGE)
  • store at 20°-25°C (68°-77°F)

do not freeze

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%.



Warnings (WARNINGS)

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

Directions (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

Do Not Use (DO NOT USE)
  • if you are allergic to any ingredient in 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.
For Pump Bottle

How to use your Docosanol Cream, 10% Pump



- 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.



 

 

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.

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Docosanol 10%

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Questions Or Comments? (QUESTIONS OR COMMENTS?)

call toll-free 1-833-285-4151 from Monday to Friday between 9 am to 6.30 pm

Manufactured by:

Encube Ethicals Private Limited

Plot No. C1,Madkaim Industrial Estate, Madkaim,

Post: Mardol, Ponda, Goa – 403 404, India

Distributed by:

Encube Ethicals, Inc.

200 Meredith Avenue, Suite 101A

Durham, NC 27713, USA

Thank you for purchasing Docosanol 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.



Principal Display Panel (PRINCIPAL DISPLAY PANEL)

For Pump Bottle - Carton Label

NDC 21922-023-17

DOCOSANOL 10% CREAM

Cold Sore/Fever Blister Treatment

Only FDA Approved to Shorten Healing Time*

Cold Sore Treatment

NET WT

2g (0.07oz)                                           































For Pump Bottle - Bottle Label

NDC 21922-023-17

DOCOSANOL 10% CREAM

Cold Sore/Fever Blister Treatment

Only FDA Approved to Shorten Healing Time*

Cold Sore Treatment

NET WT

2g (0.07oz)   









For Tube - Carton

NDC 21922-023-18

DOCOSANOL 10% CREAM

Cold Sore/Fever Blister Treatment

Only FDA Approved to Shorten Healing Time*

Cold Sore Treatment

NET WT

2g (0.07 oz) 

 





























For Tube

NDC 21922-023-18

DOCOSANOL 10% CREAM

Cold Sore/Fever Blister Treatment

Only FDA Approved to Shorten Healing Time*

Cold Sore Treatment

NET WT

2g (0.07 oz) 



 

 

 

Stop Use and Ask Doctor If (STOP USE AND ASK 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 right away.


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Raw Label Data

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