Zilactin-b Gel
FDA Label NDC 42829-550

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-b (NDC 42829-550). 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:, allergy alert:, stop use and ask a physician if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Benzocaine 10%

Purpose

Oral pain reliever

Use

temporarily relieves pain caused by:

  • canker sores
  • minor mouth sores and gum irritations
  • denture and brace pain

Flammable:

  • keep away from fire or flame

Allergy Alert:

  • do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics

Stop Use And Ask A Physician If

  • sore mouth symptoms do not improve in 7 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 a thin coat of gel 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-B Long Lasting Mouth Sore Gel to film, and immediately wipe the area with a moist gauze pad or tissue.
  • contains alcohol 65% by volume
  • store at 15-30°C (59-86°F)

Inactive Ingredients

Boric acid, hydroxypropylcellulose, propylene glycol, purified water, salicylic acid, SD alcohol 38-B, tannic acid

Otc - Questions

Call 1-888-547-5492

Distributed by Ascent Consumer Products

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