Giltuss Bucalsep

Giltuss Bucalsep
SPL v1
SPL
SPL Set ID 3fa233dc-156c-1e95-e063-6294a90a8bbd
Routes
ORAL TOPICAL
Published
Effective Date 2018-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (0.12 mg) Benzocaine (6.5 mg) Menthol (0.1 mg)
Inactive Ingredients
Propylparaben Cetylpyridinium Chloride Glycerin Methylparaben Water Propylene Glycol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-26

Description

Active ingredients Purpose Benzocaine, 6.5% ----------------- Anesthesic Menthol, 0.1% ----------------------- Anesthesic Zinc Chloride 0.12% --------------- Astringent


Medication Information

Description

Active ingredients Purpose Benzocaine, 6.5% ----------------- Anesthesic Menthol, 0.1% ----------------------- Anesthesic Zinc Chloride 0.12% --------------- Astringent

Uses

Uses

temporary relieves pain due to the following mouth and gum irritations

  • sore mouth and throat
  • canker sores
  • minor dental procedures
  • dentures or orthodontic appliance

Section 51945-4

NDC: 58552-135-01

Alcohol free

Oral Spray

Giltuss Bucalsep

Sore, Throat, Oral astringent

1 floz (30 mL)

Alcohol free, sugar free, dye free

Spearmint flavor

Warnings

Warnings

Do not use

  • IN OR NEAR THE EYES. In the event of accidental contact with the eyes, flush immediately and continuosly for 10 minutes. Seek immediate medical attention if pain or irritations persists.
  • this product for more than 7 days unless directed by a doctor or a dentist

Methemoglobinemia Warning: use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before.Stopo use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray or blue colored skin ( cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

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" anesthetic

Directions

Directions:

Adults and children 2 years of age and older

  • apply to affected area
  • gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out
  • use 4 times daily or as directed by dentist or doctor
  • children under 12 years of age should be supervised in the use of the product

Children under 2 years of age: do not use

Do Not Use

Do not use

  • for teething
  • in children under 2 years of age
  • for more than 7 days unless directed by a dentist or doctor

Other Information

Other information

Store at room temperature

Active Ingredients

Active ingredients Purpose

Benzocaine, 6.5% ----------------- Anesthesic

Menthol, 0.1% ----------------------- Anesthesic

Zinc Chloride 0.12% --------------- Astringent

Inactive Ingredients

Inactive ingredients

Cetylpyridinium chloride, glycerin, Methylparaben, Proylene Glycol, Propylparaben, Purified Water, Spearmint Flavor and Sucralose.

Questions Or Comments?

Questions or Comments?

Questions or comments?

Call 1-787-848-9114, Monday-Friday 9AM – 5PM EST

Call your doctor for medical advice in the event of side effects.

When Using This Product

When using this product

  • do not exceed recommended dosage
  • avoid contact with eyes. In case of eye contact, rinse with water

If Pregnant Or Breastfeeding

If pregnant or breastfeeding, ask a health professional before use

Indication and Usage Section

Indication and usage section

Adults and children 2 years of age and older

apply to affected area

gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out

use 4 times daily or as directed by dentist or doctor

children under 12 years of age should be supervised in the use of the product

Children under 2 years of age: do not use

Stop Use and Ask A Doctor If

Stop use and ask a doctor if

  • Sore throat is severe, persist for more than 2 days, is accompanied, or followed by fever, headache, rash,nausea or vomiting
  • Symptoms do not improve in 7 days
  • irritation, pain or redness persist or worsen
  • swelling, rash or fever develops

Keep Out of Reach of Children

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away


Structured Label Content

Uses

Uses

temporary relieves pain due to the following mouth and gum irritations

  • sore mouth and throat
  • canker sores
  • minor dental procedures
  • dentures or orthodontic appliance

Section 51945-4 (51945-4)

NDC: 58552-135-01

Alcohol free

Oral Spray

Giltuss Bucalsep

Sore, Throat, Oral astringent

1 floz (30 mL)

Alcohol free, sugar free, dye free

Spearmint flavor

Warnings

Warnings

Do not use

  • IN OR NEAR THE EYES. In the event of accidental contact with the eyes, flush immediately and continuosly for 10 minutes. Seek immediate medical attention if pain or irritations persists.
  • this product for more than 7 days unless directed by a doctor or a dentist

Methemoglobinemia Warning: use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before.Stopo use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray or blue colored skin ( cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

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" anesthetic

Directions

Directions:

Adults and children 2 years of age and older

  • apply to affected area
  • gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out
  • use 4 times daily or as directed by dentist or doctor
  • children under 12 years of age should be supervised in the use of the product

Children under 2 years of age: do not use

Do Not Use (Do not use)

Do not use

  • for teething
  • in children under 2 years of age
  • for more than 7 days unless directed by a dentist or doctor

Other Information (Other information)

Other information

Store at room temperature

Active Ingredients

Active ingredients Purpose

Benzocaine, 6.5% ----------------- Anesthesic

Menthol, 0.1% ----------------------- Anesthesic

Zinc Chloride 0.12% --------------- Astringent

Inactive Ingredients

Inactive ingredients

Cetylpyridinium chloride, glycerin, Methylparaben, Proylene Glycol, Propylparaben, Purified Water, Spearmint Flavor and Sucralose.

Questions Or Comments? (Questions or comments?)

Questions or Comments?

Questions or comments?

Call 1-787-848-9114, Monday-Friday 9AM – 5PM EST

Call your doctor for medical advice in the event of side effects.

When Using This Product (When using this product)

When using this product

  • do not exceed recommended dosage
  • avoid contact with eyes. In case of eye contact, rinse with water

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

If pregnant or breastfeeding, ask a health professional before use

Indication and Usage Section (Indication and usage section)

Indication and usage section

Adults and children 2 years of age and older

apply to affected area

gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out

use 4 times daily or as directed by dentist or doctor

children under 12 years of age should be supervised in the use of the product

Children under 2 years of age: do not use

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if

  • Sore throat is severe, persist for more than 2 days, is accompanied, or followed by fever, headache, rash,nausea or vomiting
  • Symptoms do not improve in 7 days
  • irritation, pain or redness persist or worsen
  • swelling, rash or fever develops

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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