Zilactin Red Blairex

Zilactin Red Blairex
SPL v1
SPL
SPL Set ID 42ef8bfa-c4d9-01cf-e063-6394a90ac88a
Route
TOPICAL
Published
Effective Date 2013-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Description

Drug Facts

Purpose

Cold sore/fever blister treatment, Oral pain reliever


Medication Information

Purpose

Cold sore/fever blister treatment, Oral pain reliever

Description

Drug Facts

Use

temporarily relieves pain caused by:

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

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
Flammable:
  • keep away from fire or flame
Active Ingredient

Benzyl alcohol 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 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

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

Structured Label Content

Use

temporarily relieves pain caused by:

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

Purpose

Cold sore/fever blister treatment, Oral pain reliever

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
Flammable:
  • keep away from fire or flame
Active Ingredient (Active ingredient)

Benzyl alcohol 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 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 (Inactive ingredients)

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

Advanced Ingredient Data


Raw Label Data

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