Giltuss Bucalsep BENZOCAINE MENTHOL ZINC CHLORIDE DEXTRUM LABORATORIES INC. FDA Approved 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 indication an user
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Substance Benzocaine
Route
ORAL TOPICAL
Applications
M022
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients Active ingredients Purpose Benzocaine 6.5% ----------------- Anesthesic Menthol 0.1% ----------------------- Anesthesic Zinc Chloride 0.12% --------------- Astringent Active ingredients
Inactive Ingredients
Inactive Ingredients Inactive ingredients Cetylpyridinium chloride glycerin Methylparaben Proylene Glycol Propylparaben Purified Water Spearmint Flavor and Sucralose. Inactive ingredients
Strengths
6.5 % 0.1 % 0.12 %
Quantities
30 ml
Treats Conditions
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 Indication An User

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
U3RSY48JW5 L7T10EIP3A 13S1S8SF37
Packaging

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 Active ingredients

Package Descriptions
  • 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 Active ingredients

Overview

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 indication an user

Indications & Usage

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 indication an user

Dosage & Administration

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 Directions

Warnings & Precautions
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 Allergy alert Warnings
Purpose

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 Uses

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 Do not use

When Using

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 When using this product

Stop Use & Ask a Doctor

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 Stop use and ask a doctor Stop use and ask

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 Keep out of reach of children

Questions

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. Questions


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