Indications
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 and precautions
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
Composition
- Active ingredients
- DOCOSANOL 10%
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- DOCOSANOL 10% · CreamANDA215505-001 · Over the counter
- DOCOSANOL 10% · CreamANDA217090-001 · Over the counter
- DOCOSANOL 10% · CreamANDA212385-001 · Over the counter
- DOCOSANOL 10% · CreamThis page
- DOCOSANOL 10% · CreamANDA214454-001 · Over the counter
- DOCOSANOL 10% · CreamANDA214613-001 · Over the counter
- DOCOSANOL 10% · CreamANDA215839-001 · Over the counter
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA208754.
At a glance
- Brand name
- Docosanol
- Route
- Topical
- Dosage form
- Cream
- Applicant
- P and L
- Status
- Over the counter
- FDA approval
- 19 Nov 2018
- Application
- ANDA208754-001