Docosanol Cream, 10%

Docosanol Cream, 10%
SPL v4
SPL
SPL Set ID 336b515c-5e7b-4ece-a94f-f8d8e9ce6a7b
Route
TOPICAL
Published
Effective Date 2024-05-23
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 2024-05-23
Description

Docosanol 10%

Purpose

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

Medication Information

Purpose

Cold sore/fever blister treatment

Uses

  • treats cold sores/fever blisters on the face or lips
  • shortens healing time and duration of symptoms:

                 • tingling, pain, burning, and/or itching

Description

Docosanol 10%

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

Keep out of reach of children.

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

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 Ingredient

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

PUMP PACK

NDC 51316-763-64

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:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2023 CVS/Pharmacy

CVS.com® 1-800-SHOP CVS V-38892

Made in India.

Mfg. License No.: G/25/2216

PRINCIPAL DISPLAY PANEL

TUBE PACK

NDC 51316-763-04

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:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2023 CVS/Pharmacy

CVS.com® 1-800-SHOP CVS V-38892

Made in India.

Mfg. License No.: G/25/2216

PRINCIPAL DISPLAY PANEL

TUBE PACK

NDC 51316-763-02

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:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2023 CVS/Pharmacy

CVS.com® 1-800-SHOP CVS V-38892

Made in India.

Mfg. License No.: G/25/2216

PRINCIPAL DISPLAY PANEL

PUMP PACK

NDC 51316-763-62

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:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2024 CVS/Pharmacy

CVS.com® 1-800-SHOP CVS V-38990

Made in India.

Mfg. License No.: G/25/2216

PRINCIPAL DISPLAY PANEL

TWIN TUBE PACK

NDC 51316-763-03

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 2x 2g (0.07 oz), TOTAL NET WT 4g (0.14oz)

*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:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2024 CVS/Pharmacy

CVS.com® 1-800-SHOP CVS V-38990

Made in India.

Mfg. License No.: G/25/2216

Structured Label Content

Purpose

Cold sore/fever blister treatment

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

Keep out of reach of children.

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

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 (Other information)
  • store at 20° to 25°C (68° to 77°F)
  • do not freeze
Inactive Ingredient (Inactive ingredient)

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 (PRINCIPAL DISPLAY PANEL)

PUMP PACK

NDC 51316-763-64

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:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2023 CVS/Pharmacy

CVS.com® 1-800-SHOP CVS V-38892

Made in India.

Mfg. License No.: G/25/2216

PRINCIPAL DISPLAY PANEL

TUBE PACK

NDC 51316-763-04

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:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2023 CVS/Pharmacy

CVS.com® 1-800-SHOP CVS V-38892

Made in India.

Mfg. License No.: G/25/2216

PRINCIPAL DISPLAY PANEL

TUBE PACK

NDC 51316-763-02

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:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2023 CVS/Pharmacy

CVS.com® 1-800-SHOP CVS V-38892

Made in India.

Mfg. License No.: G/25/2216

PRINCIPAL DISPLAY PANEL

PUMP PACK

NDC 51316-763-62

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:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2024 CVS/Pharmacy

CVS.com® 1-800-SHOP CVS V-38990

Made in India.

Mfg. License No.: G/25/2216

PRINCIPAL DISPLAY PANEL

TWIN TUBE PACK

NDC 51316-763-03

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 2x 2g (0.07 oz), TOTAL NET WT 4g (0.14oz)

*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:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2024 CVS/Pharmacy

CVS.com® 1-800-SHOP CVS V-38990

Made in India.

Mfg. License No.: G/25/2216

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:07.087361 · Updated: 2026-03-14T23:02:59.869199