8015275 2x med liq

8015275 2x med liq
SPL v1
SPL
SPL Set ID caf06d14-1842-a8c2-e053-2a95a90a2c65
Route
oral
Published
Effective Date 2021-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzocaine (20 mg) menthol, unspecified form (0.1 mg)
Inactive Ingredients
alcohol water fd&c yellow no. 5 polyethylene glycol 400 saccharin fd&c red no. 40

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
otc monograph not final active Since 2021-09-01

Description

Benzocaine 20% Menthol 0.1%


Medication Information

Warnings and Precautions

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

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

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

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

Active Ingredient

Benzocaine 20%

Menthol 0.1%

Indications and Usage

temporarily relieves pain associated with the following mouth and gum irritations: * toothache * sore gums * canker sores * braces * minor dental procedures

Dosage and Administration

Adults and children 2 years of age and older: * apply to affected area using applicator tip * use 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

Description

Benzocaine 20% Menthol 0.1%

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 51727-6

alcohol, flavor, polyethylene glycol, red 40, sodium saccharin, water, yellow 5

Section 51945-4

Section 55105-1

Oral anesthetic

Oral anesthetic

Section 60561-8

do not use if package has been opened * store ar 20-25°C (68-77°F)


Structured Label Content

Warnings and Precautions (34071-1)

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

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

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

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

Active Ingredient (55106-9)

Benzocaine 20%

Menthol 0.1%

Indications and Usage (34067-9)

temporarily relieves pain associated with the following mouth and gum irritations: * toothache * sore gums * canker sores * braces * minor dental procedures

Dosage and Administration (34068-7)

Adults and children 2 years of age and older: * apply to affected area using applicator tip * use 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

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 51727-6 (51727-6)

alcohol, flavor, polyethylene glycol, red 40, sodium saccharin, water, yellow 5

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Oral anesthetic

Oral anesthetic

Section 60561-8 (60561-8)

do not use if package has been opened * store ar 20-25°C (68-77°F)


Advanced Ingredient Data


Raw Label Data

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