FDA-approved label information
Reproduced from the FDA Structured Product Label via the openFDA API. Label version: November 6, 2025.
- Status
- Human Otc Drug
- Brand names
- Zilactin Early Relief Cold Sore
- Route
- Topical
- Drug class
- Pediculicide [EPC]
Indications and usage
Use temporarily relieves pain caused by: cold sores/fever blisters canker sores, mouth sores gum irritations
Warnings (older label format)
Warnings Flammable: keep away from fire or flame Stop use and ask a physician if sore mouth symptoms do not improve in 7 days condition worsens or symptoms clear up and occur again within a few days swelling, rash or fever develops irritation, pain or redness persists or worsens apply only to affected area do not exceed recommended dosage avoid contact with the eyes do not use for more than 7 days unless directed by a physician or dentist Keep out of reach of children . If swallowed, get medical help or contact a poison control center immediately.
Source: US Food and Drug Administration, via the openFDA API. The FDA does not review, endorse or verify third-party reproductions of this data, and label information may have been updated since it was retrieved.
Read the current full label on DailyMed
FDA approval applies to the uses listed on the label. Approval status in your country may differ.
