Anesgerm LA MUELA

Manufacturer
Germa Products, LLC
Effective date
2025-10-10
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:38:39

Label at a glance#

ProductAnesgerm LA MUELA Fast Pain Relief
Active ingredientBENZOCAINE
Label structure10 sections

Indications and 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.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Do Not Use if

OTC - WHEN USING SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTC - PURPOSE SECTION

Pain Reliever

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Uses

INDICATIONS & USAGE SECTION

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 SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anesgerm La MuelaAnesgerm La Muela

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN6
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD6
308657benzocaine 20 % Mucous Membrane Topical SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130790933101935GTIN-13: 0790933101935
EAN-13: 0790933101935
GTIN-12: 790933101935
UPC-A: 790933101935
GTIN storage (14 digits): 00790933101935
Anesgerm-(La-Muela).jpg

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73635-7101-5Anesgerm LA MUELAFast Pain Relief14.8 mL in 1 BOTTLE, WITH APPLICATORLIQUID14.86
73635-7101-5Anesgerm LA MUELAFast Pain Relief1 in 1 BOXLIQUID16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73635-710173635-7101-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-10-15full-release2026-06-01 00:25:51

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anesgerm LA MUELA Fast Pain ReliefBENZOCAINE 20%Germa Products, LLCbf7842a2-9c0b-3fc3-e053-2995a90a36c12025-10-10WarningsExact identifier
ndc (package): 73635-7101-5
ndc (product): 73635-7101
ndc11 (package): 73635710105
spl id: 40d07e93-4ae8-9c91-e063-6394a90ac00a
spl set id: bf7842a2-9c0b-3fc3-e053-2995a90a36c1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.