FDA Label for Anesgerm La Muela Fast Pain Relief
View Indications, Usage & Precautions
Anesgerm La Muela Fast Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Germa Products, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Benzocaine 20%
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.
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.
Purpose
Pain Reliever
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.
Other Information
Store between 15° to 30°C (59° to 86°F).
Inactive Ingredients
Clove Oil, Ethyl Alcohol, Glycerin, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Sodium Methylparaben.
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.
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.
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