Benzoin Compound Tincture
FDA Label NDC 54162-100

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 Benzoin Compound Tincture (NDC 54162-100). 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, dosage & administration, inactive ingredient, storage and handling, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Intended Use

→ Directions

→ Warnings

→ Dosage & Administration

→ Inactive Ingredient

→ Storage And Handling

→ Otc - Keep Out Of Reach Of Children

→ Package Label.principal Display Panel

Active Ingredient

Tincture Benzoin compound

Intended Use

Antiseptic preparation maintains skin
integrity and protects skin from adhesive and harsh body
fluids. Forms a fine coating over skin, abrasions, wounds
and oral lesions.

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.

Warnings

For external use only.
Do not apply to or near eyes. Do not swallow. In case of accidental
ingestion seek professional assistance or contact poison control
center immediately.
FLAMMABLE: Keep away from sparks, heat and flames.
When using this product:
Discontinue use and consult a physician if irritation persists,
worsens or if swelling or rash develops. Do not use for more
than 10 days unless directed by your physician.