Benzoin Tincture Liquid
FDA Label NDC 0395-0247

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Humco Holding Group, Inc. for the product Benzoin Tincture (NDC 0395-0247). 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 active ingredient, purpose, use, warnings, when using this product, stop use and consult a dentist or doctor if, keep out of the reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzoin

Purpose

Oral mucosal protectant

Use

Forms a coating over wound for protecting recurring canker sores

Warnings

For externl use only. Do not swallow. Do not exceed recommended dosage.

When Using This Product

Children under 12 years of age should be supervised in the use of this product.

Do not use more than 7 days unless directed by a dentist or doctor.

Stop Use And Consult 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.

Keep Out Of The Reach Of Children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immeditely.

Directions

Adult and children 6 months of age and older: Dry the affected area, with cotton swab, apply undiluted to the affected area not more than every 2 hours.

Children under 6 months of age: Consult a dentist or doctor.

Inactive Ingredients

Alcohol 77%, Aloe, Stoax, tolu Balsam.

Questions Or Comments?

1-800-662-3435

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