OTC Medication Information: Cold Sore Fever Blister Treatment

COLD SORE FEVER BLISTER TREATMENT- docosanol cream
Topco Associates

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
  • 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 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° 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 toll free 1-888-423-0139

Principal Display Panel

†Compare to the active ingredient in Abreva®

Docosanol Cream, 10%

Cold sore/fever blister treatment

  • Only FDA approved medicine to shorten healing time*
  • Cold sore treatment

NET WT 2 g (0.07 oz)

*Docosanol Cream, 10% contains the only OTC medicine approved by the FDA to shorten healing time and duration of symptoms.

†This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Abreva®.

RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

Package Label

Docosanol 10%
(click image for full-size original)

TOPCARE HEALTH Cold Sore Fever Blister Treatment

COLD SORE FEVER BLISTER TREATMENT
docosanol cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76162-818
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCOSANOL (DOCOSANOL) DOCOSANOL 100 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
LIGHT MINERAL OIL
PROPYLENE GLYCOL
WATER
SUCROSE DISTEARATE
SUCROSE STEARATE
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76162-818-07 1 TUBE in 1 PACKAGE contains a TUBE
1 2 g in 1 TUBE This package is contained within the PACKAGE (76162-818-07)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212385 12/31/2023
Labeler — Topco Associates (006935977)

Revised: 11/2023 Topco Associates

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.