Drugplain

Cold Sore Fever Blister Treatment 100 mg/g

Docosanol · CREAM · Topco Associates

No Recall History
Plain English

Docosanol cream is an over-the-counter topical treatment applied directly to the skin to help reduce the severity and duration of cold sores and fever blisters caused by herpes simplex virus. It works by preventing the virus from entering healthy cells.

Key Facts

Brand Name
Cold Sore Fever Blister Treatment
Generic Name
Docosanol
NDC Code (Product)
76162-818
Manufacturer
Topco Associates
Strength
100 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
ANDA212385
Marketing Start
12/31/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective384 reports
condition aggravated62 reports
product use in unapproved indication38 reports
oral herpes33 reports
incorrect product administration duration26 reports
drug effective for unapproved indication25 reports
product use issue19 reports
drug effect less than expected17 reports
lip swelling16 reports
wrong technique in product usage process15 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

Warnings

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

Frequently Asked Questions

What is Cold Sore Fever Blister Treatment used for?

Docosanol cream is an over-the-counter topical treatment applied directly to the skin to help reduce the severity and duration of cold sores and fever blisters caused by herpes simplex virus. It works by preventing the virus from entering healthy cells.

Is Cold Sore Fever Blister Treatment a controlled substance?

Cold Sore Fever Blister Treatment is not classified as a controlled substance by the DEA.

What is the generic name for Cold Sore Fever Blister Treatment?

The generic name for Cold Sore Fever Blister Treatment is Docosanol. There are 7 other brand versions of Docosanol.

What is the NDC code for Cold Sore Fever Blister Treatment 100 mg/g?

The NDC (National Drug Code) for Cold Sore Fever Blister Treatment 100 mg/g is 76162-818, listed by Topco Associates.