Zilactin B

Zilactin B
SPL v1
SPL
SPL Set ID 42eeb3d4-bac6-4e29-e063-6294a90a644d
Route
TOPICAL
Published
Effective Date 2013-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (0.1 g)
Inactive Ingredients
Boric Acid Hydroxypropyl Cellulose (type M) Propylene Glycol Salicylic Acid Alcohol Peppermint Oil Tannic Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-06
Description

Drug Facts

Purpose

Oral pain reliever

Medication Information

Purpose

Oral pain reliever

Description

Drug Facts

Use

temporarily relieves pain caused by:

  • canker sores
  • minor mouth sores and gum irritations
  • denture and brace pain
Section 42229-5

Drug Facts

Section 50565-1

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

Section 51945-4

Section 53413-1

Call 1-888-547-5492

Distributed by Ascent Consumer Products

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 years adult supervision should be given in the use of this product
children under 2 years do not use, consult a physician or dentist
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
Active Ingredient

Benzocaine 10%

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

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

Structured Label Content

Use

temporarily relieves pain caused by:

  • canker sores
  • minor mouth sores and gum irritations
  • denture and brace pain
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call 1-888-547-5492

Distributed by Ascent Consumer Products

Purpose

Oral pain reliever

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 years adult supervision should be given in the use of this product
children under 2 years do not use, consult a physician or dentist
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
Active Ingredient (Active ingredient)

Benzocaine 10%

Other Information (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 (Inactive ingredients)

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

Stop Use and Ask A Physician If (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:56.776894 · Updated: 2026-03-14T23:13:27.116919