Docosanol Cream
FDA Label NDC 61269-989

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H2-pharma, Llc for the product Docosanol (NDC 61269-989). 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 other, active ingredient, purpose, uses, allergy alert, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

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

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • adults and children 12 years or over:
    • wash hands before and after applying cream
    • apply to affected area on the 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°-25°C (68°-77°F)
  • do not freeze

Inactive Ingredients

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

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel - 2 G Bottle Package

NDC 61269-989-37
†Compare to the active
ingredient in Abreva®

Docosanol
Cream 10%
Cold sore/fever blister treatment

Portable convenient pump

Only FDA-approved medicine
to shorten healing time*

Cold sore treatment

Net wt. 2 g
(0.07 oz)

H2 pharma

Principal Display Panel (2 g Bottle Package)

Principal Display Panel (2 g Bottle Package)

* Please review the disclaimer below.