Active Ingredient
Benzoin
Benzoin Compound Tincture Liquid
FDA Label NDC 0395-0243
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 Compound Tincture (NDC 0395-0243). 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 reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral mucosal protectant
Use
Forms a coating over wound for protecting recurring canker sores
Warnings
For external 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 for 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 Reach Of Children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Directions
Adults and children 6 months of age and older: Dry the affected area, with cotton swab, apply undiluted to the affected area not more often than every 2 hours.
Children under 6 months of age: Consult a dentist or doctor.
Other Information
Flammable: Keep away from spark, heat or flame.
Inactive Ingredients
Alcohol 77%, Aloe, Storax, Tolu Balsam
Principal Display Panel - 16Oz
16 Oz (L024316001 Benzoin Compound 16oz Web)
Principal Display Panel - 2 Oz
2 Oz (L024392001 Benzoin Compound Tr 2 Oz. Web)
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