anesgerm (la muella)

anesgerm (la muella)
SPL v6
SPL
SPL Set ID bf7842a2-9c0b-3fc3-e053-2995a90a36c1
Route
topical
Published
Effective Date 2021-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzocaine (200 mg)
Inactive Ingredients
propylene glycol saccharin sodium glycerin clove oil polyethylene glycol 100000 alcohol methylparaben sodium

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-03-29

Purpose

Pain Reliever

Description

Benzocaine 20%


Medication Information

Warnings

Warnings:

Do not exceed recommended dosage

Keep out of reach of children

In case of overdose, get medical help immediately.

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a 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. 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.

Do not use:

for more than 7 days unless directed by a dentist or doctor

for teethings in children under 2 years of age.

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. If a skin reaction occurs, stop use and seek medical help right away.

Stop use and ask a dentist or doctor if:

sore mouth symptoms do not improve in 7 days.

irritation, pain or redness persists or worsens.

swelling, rash or fever develops.

These symptoms may be a sign of infection or a serious condition.

Uses

Uses ■ for the temporary relief of pain due to. ■ toothache ■ minor irritation or injury of the mouth & gums ■ irritation cause by dentures or orthodontic appliances ■ sore gums.

Purpose

Pain Reliever

Directions

Adults & children, 12 yrs of age & older ■ Apply to the affected area up to 4 times daily or as directed by a dentist or doctor.

Children 2 yrs of age & older ■ As directed by a dentist or doctor.

Children under 2 years of age ■ Do not use.

Other Information

Store between 15º to 30ºC (59º to 86ºF).

Inactive Ingredients

Clove Oil, Ethyl Alcohol, Glycerin, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Sodium Methylparaben.

Description

Benzocaine 20%

Section 51945-4

Warning

Warnings: Do not exceed recommended dosage. Keep out of reach of children. In case of overdose, get medical help immediately.

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a 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.

Do Not Use If

Do not use ■ for more than 7 days unless directed by a dentist or doctor ■ for teethings. ■ in children under 2 years of age.

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. If a skin reaction occurs, stop use and seek medical help right away.

Stop use and ask a dentist or doctor if ■ sore mouth symptoms do not improve in 7 days ■ irritation, pain or redness persists or worsens ■ swelling, rash or fever develops. ■ These symptoms may be a sign of infection or a serious condition.

Active Ingredient

Benzocaine 20%


Structured Label Content

Warnings

Warnings:

Do not exceed recommended dosage

Keep out of reach of children

In case of overdose, get medical help immediately.

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a 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. 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.

Do not use:

for more than 7 days unless directed by a dentist or doctor

for teethings in children under 2 years of age.

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. If a skin reaction occurs, stop use and seek medical help right away.

Stop use and ask a dentist or doctor if:

sore mouth symptoms do not improve in 7 days.

irritation, pain or redness persists or worsens.

swelling, rash or fever develops.

These symptoms may be a sign of infection or a serious condition.

Uses

Uses ■ for the temporary relief of pain due to. ■ toothache ■ minor irritation or injury of the mouth & gums ■ irritation cause by dentures or orthodontic appliances ■ sore gums.

Purpose

Pain Reliever

Directions

Adults & children, 12 yrs of age & older ■ Apply to the affected area up to 4 times daily or as directed by a dentist or doctor.

Children 2 yrs of age & older ■ As directed by a dentist or doctor.

Children under 2 years of age ■ Do not use.

Other Information

Store between 15º to 30ºC (59º to 86ºF).

Inactive Ingredients

Clove Oil, Ethyl Alcohol, Glycerin, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Sodium Methylparaben.

Section 51945-4 (51945-4)

Warning

Warnings: Do not exceed recommended dosage. Keep out of reach of children. In case of overdose, get medical help immediately.

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a 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.

Do Not Use If (Do Not Use if)

Do not use ■ for more than 7 days unless directed by a dentist or doctor ■ for teethings. ■ in children under 2 years of age.

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. If a skin reaction occurs, stop use and seek medical help right away.

Stop use and ask a dentist or doctor if ■ sore mouth symptoms do not improve in 7 days ■ irritation, pain or redness persists or worsens ■ swelling, rash or fever develops. ■ These symptoms may be a sign of infection or a serious condition.

Active Ingredient

Benzocaine 20%


Advanced Ingredient Data


Raw Label Data

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