Ultracare

Ultracare
SPL v2
SPL
SPL Set ID f5dd8fa8-0b6a-5a30-e053-2995a90ad194
Routes
DENTAL TOPICAL PERIODONTAL
Published
Effective Date 2023-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Polyethylene Glycol 400 Potassium Sodium Saccharate Polyethylene Glycol 3350

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-08

Description

Benzocaine 20% w/v

Purpose

Oral Anesthetic

Dosage and Administration

Mucosa should be dried prior to application. Removal of excess saliva with cotton rolls or saliva ejectors will minimize dilution of the local anesthetic. Sterile cotton or gauze should be used in applying anesthetic to mucosa. Care must be taken to avoid cross-contamination between patients. Total dose should not exceed the amout required for anethesia. - Apply to the affected area. - Remain in place for at least 1 minute and then spit. - Use up to 4 times daily or as directed by a dentist or doctor. - Do not exceed recommended dosage. - This product is for adultsand children 2 years of age and older. - Chidlren under 2 years of age should consult a dentist or a doctor.


Medication Information

Purpose

Oral Anesthetic

Dosage and Administration

Mucosa should be dried prior to application. Removal of excess saliva with cotton rolls or saliva ejectors will minimize dilution of the local anesthetic. Sterile cotton or gauze should be used in applying anesthetic to mucosa. Care must be taken to avoid cross-contamination between patients. Total dose should not exceed the amout required for anethesia.

- Apply to the affected area.

- Remain in place for at least 1 minute and then spit.

- Use up to 4 times daily or as directed by a dentist or doctor.

- Do not exceed recommended dosage.

- This product is for adultsand children 2 years of age and older.

- Chidlren under 2 years of age should consult a dentist or a doctor.

Description

Benzocaine 20% w/v

Uses

Reduce pain or discomfort caused by - minor dental procedures - minor gum injury - canker sores - sore throat - minor mouth or gum irritations caused by dentures or orthodontic applicances

Section 34088-5

If more than normal usage amount if accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not exceed recommended dosage.

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor (pharmacist) before use if you have severely traumatized, infected mucosal areas or areas of the posterior pharynx that might obtund protective reflexes.

Section 50569-3

Stop use and ask a doctor if

- Sore throat is severe and more than 2 days

- Fever, headache, rash, nausea, or vomiting develops

- Mouth sore does not go away within 10 days

- Irritation, pain or redness worsens

Section 50570-1

Do not use in patients with history of hypersensitivity to any ester-type local anesthetics. Do not use the product for teething or in infants and children younger than 2 years.

Do not use if you have history of allergy to any "caine" local anesthetics.

Avoid contact with eyes.

Section 51945-4

Storage

Avoid excessive heat above 40C (104F).

Net content 1oz. (30 grams)

Warnings

For external use only.

Indications

Anesthesia of mucous membrane of oropharynx. Minimizes the pain of ulcers, needle puncture, deep scaling procedures, and the application of matrix bands. Also an aid in the taking of impressions or intraoral radiographs of patients with an excessive gag reflexes.

Active Ingredient

Benzocaine 20% w/v

Inactive Ingredients

Polyethylene Glycol 400 (PEG 400) NF, Polyethylene Glycol 3350 (3550) NF, Sodium Saccharin, natural and artificial flavors.

Methemoglobinemia Warning

Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated prompltly because it reduces the amount of oxygen carried in blood. Cease use and seek immediate medical attention if one of the following symptoms develops: -Pale, gray, or blue colored skin (cyanosis) - Headache - Rapid heart rate - Shortness of breath _ Dizziness or lightheadedness - Fatigue or lack of energy


Structured Label Content

Uses

Reduce pain or discomfort caused by - minor dental procedures - minor gum injury - canker sores - sore throat - minor mouth or gum irritations caused by dentures or orthodontic applicances

Section 34088-5 (34088-5)

If more than normal usage amount if accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not exceed recommended dosage.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor (pharmacist) before use if you have severely traumatized, infected mucosal areas or areas of the posterior pharynx that might obtund protective reflexes.

Section 50569-3 (50569-3)

Stop use and ask a doctor if

- Sore throat is severe and more than 2 days

- Fever, headache, rash, nausea, or vomiting develops

- Mouth sore does not go away within 10 days

- Irritation, pain or redness worsens

Section 50570-1 (50570-1)

Do not use in patients with history of hypersensitivity to any ester-type local anesthetics. Do not use the product for teething or in infants and children younger than 2 years.

Do not use if you have history of allergy to any "caine" local anesthetics.

Avoid contact with eyes.

Section 51945-4 (51945-4)

Purpose

Oral Anesthetic

Storage

Avoid excessive heat above 40C (104F).

Net content 1oz. (30 grams)

Warnings

For external use only.

Indications

Anesthesia of mucous membrane of oropharynx. Minimizes the pain of ulcers, needle puncture, deep scaling procedures, and the application of matrix bands. Also an aid in the taking of impressions or intraoral radiographs of patients with an excessive gag reflexes.

Active Ingredient

Benzocaine 20% w/v

Inactive Ingredients

Polyethylene Glycol 400 (PEG 400) NF, Polyethylene Glycol 3350 (3550) NF, Sodium Saccharin, natural and artificial flavors.

Dosage and Administration

Mucosa should be dried prior to application. Removal of excess saliva with cotton rolls or saliva ejectors will minimize dilution of the local anesthetic. Sterile cotton or gauze should be used in applying anesthetic to mucosa. Care must be taken to avoid cross-contamination between patients. Total dose should not exceed the amout required for anethesia.

- Apply to the affected area.

- Remain in place for at least 1 minute and then spit.

- Use up to 4 times daily or as directed by a dentist or doctor.

- Do not exceed recommended dosage.

- This product is for adultsand children 2 years of age and older.

- Chidlren under 2 years of age should consult a dentist or a doctor.

Methemoglobinemia Warning (Methemoglobinemia warning)

Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated prompltly because it reduces the amount of oxygen carried in blood. Cease use and seek immediate medical attention if one of the following symptoms develops: -Pale, gray, or blue colored skin (cyanosis) - Headache - Rapid heart rate - Shortness of breath _ Dizziness or lightheadedness - Fatigue or lack of energy


Advanced Ingredient Data


Raw Label Data

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