Zilactin Early Relief Cold Sore .1 g/g

benzyl alcohol · GEL · ASCENT CONSUMER PRODUCTS, INC

No Recall History

Plain English

Zilactin Early Relief Cold Sore is a gel containing benzyl alcohol at .1 g/g, taken topical. Manufactured by ASCENT CONSUMER PRODUCTS, INC.

Key Facts

Brand Name: Zilactin Early Relief Cold Sore
Generic Name: benzyl alcohol
NDC Code (Product): 42829-468
Manufacturer: ASCENT CONSUMER PRODUCTS, INC
Strength: .1 g/g
Dosage Form: GEL
Route: TOPICAL
Marketing Status
Application #: M022
Drug Class: Pediculicide [EPC]
Marketing Start: 11/06/2025

Recall History

No Recall History

Side Effects Reported to FDA

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

toxicity to various agents25 reports

drug administered to patient of inappropriate age16 reports

metabolic acidosis12 reports

drug interaction9 reports

atrial fibrillation8 reports

staphylococcal bacteraemia6 reports

cerebellar stroke5 reports

diarrhoea5 reports

drug abuse5 reports

gasping syndrome5 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use temporarily relieves pain caused by: cold sores/fever blisters canker sores, mouth sores gum irritations

Dosage & Administration

Directions adults and children 2 years and older dry affected area. Apply with cotton swab or clean finger up to 4 times daily. Allow to dry 30-60 seconds. children under 12 years adult supervision should be given in the use of this product children under 2 years do not use, consult a physician or dentist

Warnings

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.

Frequently Asked Questions

What is Zilactin Early Relief Cold Sore used for?

Zilactin Early Relief Cold Sore contains benzyl alcohol. It is a gel taken topical. Consult your doctor for specific uses.

Is Zilactin Early Relief Cold Sore a controlled substance?

Zilactin Early Relief Cold Sore is not classified as a controlled substance by the DEA.

What is the generic name for Zilactin Early Relief Cold Sore?

The generic name for Zilactin Early Relief Cold Sore is benzyl alcohol. There are 10 other brand versions of benzyl alcohol.

What is the NDC code for Zilactin Early Relief Cold Sore .1 g/g?

The NDC (National Drug Code) for Zilactin Early Relief Cold Sore .1 g/g is 42829-468, listed by ASCENT CONSUMER PRODUCTS, INC.

Product NDC

42829-468

Package NDC

42829-468-02

Other Benzyl Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)