Zilactin Gel
FDA Label NDC 42829-468

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ascent Consumer Products, Inc for the product Zilactin (NDC 42829-468). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, flammable:, stop use and ask a physician if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Active Ingredient

Benzyl alcohol 10%

Purpose

Cold sore/fever blister treatment, Oral pain reliever

Use

temporarily relieves pain caused by:

  • cold sores/fever blisters
  • canker sores, mouth sores
  • gum irritations

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

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 yearsadult supervision should be given in the use of this product
children under 2 yearsdo not use, consult a physician or dentist

Other Information

  • do not peel off protective film. Attempting to peel off film may result in skin irritation or tenderness. To remove film, first apply another coat of Zilactin to film, and immediately wipe the area with a moist gauze pad or tissue.
  • contains alcohol 68% by volume
  • store at 15-30°C (59-86°F)

Inactive Ingredients

boric acid, hydroxypropylcellulose, propylene glycol, purified water, salicylic acid, SD alcohol 37, tannic acid

Otc - Questions

Call 1-888-547-5492

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