Benz Protect
FDA Label NDC 54162-099

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Benz Protect (NDC 54162-099). 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, intended use, directions, warnings, stop use and ask a dentist or doctor if, storage and handling, keep out of reach of children., otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzoin Compound Tincture (Benzoin, Aloe, Storax, Tolu, Balsam, Alcohol)

Intended Use

  • Forms a coating over a wound
  • For protecting recurring canker sores

Directions

For adults and supervised children 2 years and older:
Dry affected area of skin or oral mucosa. Apply with a cotton
swab or gauze every 3-4 hours or as directed by your physician.

Adults and children 6 months or age and older: Dry affected area of oral mucosa. Apply the swab applicator every 3-4 hours or as directed by physician. Children under 6 months of age: Consult a dentist or Doctor

Warnings

Do not

  • Use this product for more than 7 days unless directed by a dentist or doctor
  • Exceed recommended dosage

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 develop

Storage And Handling

Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature] in tight, light-resistant containers. Avoid exposure
to direct sunlight or heat.

Keep Out Of Reach Of Children.

In case of accidental ingestions, seek professional assistance or contact a Poison Control Center immediately

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

* Please review the disclaimer below.