ANESGERM LA MUELA FAST PAIN RELIEF- benzocaine 20% liquid

Anesgerm LA MUELA by

Drug Labeling and Warnings

Anesgerm LA MUELA by is a Otc medication manufactured, distributed, or labeled by Germa Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 15º to 30ºC (59º to 86ºF).

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANESGERM LA MUELA  FAST PAIN RELIEF
benzocaine 20% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73635-7101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
GLYCERIN (UNII: PDC6A3C0OX)
CLOVE OIL (UNII: 578389D6D0)
POLYETHYLENE GLYCOL 100000 (UNII: V46Y6OJ5QB)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73635-7101-5	1 in 1 BOX	03/29/2019
1		14.8 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	03/29/2019

Labeler - Germa Products, LLC (116626935)