Docosanol Cream
FDA Label NDC 46708-682

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alembic Pharmaceuticals Limited for the product Docosanol (NDC 46708-682). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

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

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

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

Tube Pack (91169ef2 B68b 4da3 B698 2bfc01f441cf 01)

Tube Pack (91169ef2 B68b 4da3 B698 2bfc01f441cf 01)

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

Pump Pack (91169ef2 B68b 4da3 B698 2bfc01f441cf 02)

Pump Pack (91169ef2 B68b 4da3 B698 2bfc01f441cf 02)

* Please review the disclaimer below.