SPL v5
SPL
SPL Set ID 996f7989-17ce-5b28-e053-2995a90af8b8
Route
ORAL
Published
Effective Date 2020-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g) Menthol (0.26 g) Zinc Cation (0.15 g)
Inactive Ingredients
Polyethylene Glycol 3350 Saccharin Polyethylene Glycol 400 Sorbic Acid Glycyrrhizin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-06 Until 2027-11-01

Description

Acive Ingredients Purpose Benzocaine 20% .......... Oral Pain Reliever Menthol 0.26% ............. Oral Pain Reliever Zinc Chloride 0.15% .... Oral Astringent


Medication Information

Indications and Usage

Methemoglobinemia warning: use of this product may cause methemoglobinema, a serious condition that must be treated promptly because it reduces the amount of oxygen in the blood. This can occur even if you have used this prouct before. Stop 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

Description

Acive Ingredients Purpose Benzocaine 20% .......... Oral Pain Reliever Menthol 0.26% ............. Oral Pain Reliever Zinc Chloride 0.15% .... Oral Astringent

Use

Use * for the temporary relief of pain due to minor irritation or injury of the mouth and gums

Section 50565-1

Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic reaction occurs

Section 50570-1

Do not use * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age

Section 51727-6

Inactive ingredients ammonium glycyrrhizate, favor, PEG-8, PEG-75, sodium saccharin, sorbic acid

Section 51945-4

Toothache and Gum Reliever

20% benzocaine to relive oral pain

Astringent to help prevent infection

Menthol to soothe gums

3x medicated

oral pain reliever/astringent

Net Wt 0.42 oz (11.9 g)

Section 55106-9

Acive Ingredients Purpose

Benzocaine 20% .......... Oral Pain Reliever

Menthol 0.26% ............. Oral Pain Reliever

Zinc Chloride 0.15% .... Oral Astringent

Section 60561-8

Other information * do not use if tip is cut prior to opening * this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted * do not use continuously ( this formula will stay in place for extended duration of relief * avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Directions

Directions * cut open tip of tube on score mark * do not use if tip is cut prior to opening * adults adn children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor * children under 12 years of age should be supervised in the use of this product * children under 2 years of age: do not use

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


Structured Label Content

Use

Use * for the temporary relief of pain due to minor irritation or injury of the mouth and gums

Indications and Usage (34067-9)

Methemoglobinemia warning: use of this product may cause methemoglobinema, a serious condition that must be treated promptly because it reduces the amount of oxygen in the blood. This can occur even if you have used this prouct before. Stop 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

Section 50565-1 (50565-1)

Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic reaction occurs

Section 50570-1 (50570-1)

Do not use * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age

Section 51727-6 (51727-6)

Inactive ingredients ammonium glycyrrhizate, favor, PEG-8, PEG-75, sodium saccharin, sorbic acid

Section 51945-4 (51945-4)

Toothache and Gum Reliever

20% benzocaine to relive oral pain

Astringent to help prevent infection

Menthol to soothe gums

3x medicated

oral pain reliever/astringent

Net Wt 0.42 oz (11.9 g)

Section 55106-9 (55106-9)

Acive Ingredients Purpose

Benzocaine 20% .......... Oral Pain Reliever

Menthol 0.26% ............. Oral Pain Reliever

Zinc Chloride 0.15% .... Oral Astringent

Section 60561-8 (60561-8)

Other information * do not use if tip is cut prior to opening * this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted * do not use continuously ( this formula will stay in place for extended duration of relief * avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Directions

Directions * cut open tip of tube on score mark * do not use if tip is cut prior to opening * adults adn children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor * children under 12 years of age should be supervised in the use of this product * children under 2 years of age: do not use

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


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