Label: ANESGERM LA MUELA FAST PAIN RELIEF- benzocaine 20% liquid

  • 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.

  • 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

    Anesgerm La Muela

  • INGREDIENTS AND APPEARANCE
    ANESGERM LA MUELA  FAST PAIN RELIEF
    benzocaine 20% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73635-7101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73635-7101-51 in 1 BOX03/29/2019
    114.8 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34803/29/2019
    Labeler - Germa Products, LLC (116626935)