Anesgerm
FDA Label NDC 10095-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by World Perfumes, Inc for the product Anesgerm (NDC 10095-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, dosage & administration, indications & usage, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                                       Purpose

Benzocaine 20% .................................... Pain Reliever

Otc - Purpose

Uses

for the temporary relief of pain due to:

  • toothache
  • minor irritation or injury of the mouth and gums
  • infection cause by dentures or orthodontic appliances
  • sore gums due to teething in infants and children 4 months of age and older

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help immediately.

Dosage & Administration

Directions

children under 12 years of age should be supervised in the use of this product.  Adults and children 12 years of age and older:

  • apply to the affected area up to 4 times a day or as directed by a dentist or doctor

    • Children under 2 years of age:

    • consult a dentist or doctor

      • Teething Infants 4 months of age and over:

      • apply to the affected area up to 4 times daily or as directed by a dentist or doctor

        • Infants under 4 months of age:

        • consult a dentist or doctor

Indications & Usage

GERMA

Anesterm

Maximum Strength Oral Pain Reliever

20% Benzocaine PLUS Oil of Cloves

Fast Pain Relief

Easy To Apply

  • Toothache
  • Sore Gums
  • Teething
  • Denture Irritation
  • Braces Irritation

Warnings

Warnings

Do not exceed recommended dosage.

Do not use

  • for more than 7 days unless directed by a dentist or doctor
  • if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

    • Stop use and ask a doctor if

    • sore mouth symptoms do not improve in 7 days
    • infection, pain, or redness persists or worsens
    • swelling, rash or fever develops
    • fever & nasal congestion are present in teething infants 4 months of age and over

      • These symptoms may be a sign of infection or a serious condition.

Inactive Ingredient

Inactive Ingredients

polyethylene glycol-75, polyethylene glycol-8, glycerin, propyl paraben, methyl paraben, sodium saccharin, clove oil

Package Label.Principal Display Panel

Label Image (Anesgerm)

Label Image (Anesgerm)

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