Label: ANESGERM LA MUELA FAST PAIN RELIEF- benzocaine 20% liquid
- NDC Code(s): 73635-7101-5
- Packager: Germa Products, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 9, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
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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
- Purpose
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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
- Inactive Ingredients
- Uses
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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
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INGREDIENTS AND APPEARANCE
ANESGERM LA MUELA FAST PAIN RELIEF
benzocaine 20% liquidProduct 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)