Docosanol Cream, 10%

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 2025-05-08

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 46708-682-01

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

Pump Pack

NDC 46708-682-03

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

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 46708-682-01

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

Pump Pack

NDC 46708-682-03

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

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.

Advanced Ingredient Data

[{"name": "DOCOSANOL", "unii": "9G1OE216XY", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE DISTEARATE", "unii": "33X4X4B90S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE STEARATE", "unii": "274KW0O50M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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": "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 46708-682-01 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 Pump Pack NDC 46708-682-03 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", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information