Docosanol Cream, 10%

Docosanol Cream, 10%
SPL v1
SPL
SPL Set ID ccbb5e6d-cb85-449c-a480-28225d744f4d
Route
TOPICAL
Published
Effective Date 2024-01-04
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 2024-01-04

Description

Docosanol 10%

Purpose

Cold sore/fever blister treatment


Medication Information

Purpose

Cold sore/fever blister treatment

Description

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

Do not use

  • if you are allergic to any ingredient in this product

When using this product

  • 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

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

Docosanol 10%

Other Information
  • store at 20° to 25°C (68° to 77°F)
  • do not freeze
Inactive Ingredients

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

Questions Or Comments?

Call 1-866-210-9797 Monday-Friday 9AM-6PM EST

Principal Display Panel

Tube Pack

NDC 0713-0353-02

Docosanol Cream, 10%

Compare to the active ingredient in Abreva®**

Cold Sore/Fever Blister Treatment

Non-prescription Medicine to Shorten Healing Time*

Cold Sore Treatment

For Topical Use Only

NET WT 2g (0.07 oz)

**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.

*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:

Cosette Pharmaceuticals, Inc.

South Plainfield, NJ 07080

Made in India.

Code No.: GUJ/DRUGS/G/25/2216

2

Pump Pack

NDC 0713-0353-62

Docosanol Cream, 10%

Compare to the active ingredient in Abreva®*

Cold Sore/Fever Blister Treatment

Non-prescription Medicine to Shorten Healing Time**

Cold Sore Treatment

For Topical Use Only

NET WT 2g (0.07 oz)

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.

**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:

Cosette Pharmaceuticals, Inc.

South Plainfield, NJ 07080

Made in India.

Code No.: GUJ/DRUGS/G/25/2216

4
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


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

Do not use

  • if you are allergic to any ingredient in this product

When using this product

  • 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

  • your cold sore gets worse or the cold sore is not healed within 10 days
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
Active Ingredient (Active ingredient)

Docosanol 10%

Other Information (Other information)
  • store at 20° to 25°C (68° to 77°F)
  • do not freeze
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-866-210-9797 Monday-Friday 9AM-6PM EST

Principal Display Panel

Tube Pack

NDC 0713-0353-02

Docosanol Cream, 10%

Compare to the active ingredient in Abreva®**

Cold Sore/Fever Blister Treatment

Non-prescription Medicine to Shorten Healing Time*

Cold Sore Treatment

For Topical Use Only

NET WT 2g (0.07 oz)

**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.

*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:

Cosette Pharmaceuticals, Inc.

South Plainfield, NJ 07080

Made in India.

Code No.: GUJ/DRUGS/G/25/2216

2

Pump Pack

NDC 0713-0353-62

Docosanol Cream, 10%

Compare to the active ingredient in Abreva®*

Cold Sore/Fever Blister Treatment

Non-prescription Medicine to Shorten Healing Time**

Cold Sore Treatment

For Topical Use Only

NET WT 2g (0.07 oz)

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.

**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:

Cosette Pharmaceuticals, Inc.

South Plainfield, NJ 07080

Made in India.

Code No.: GUJ/DRUGS/G/25/2216

4
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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