Franklynumb 1
FDA Label NDC 54723-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sambria Pharmaceuticals, Llc for the product Franklynumb 1 (NDC 54723-003). 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 drug facts, active ingredient, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Benzocaine 20% 

Purpose

External Analgesic

Uses

For temporary relief of pain and itching due to minor skin irritations.

Warnings

For external use only.
Avoid contact with eyes.

Do not use in large quantities, particularly over the raw surfaces or blistered area 

Stop use and ask a doctor if

condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within the few days. Discontinue use.

Keep Out Of Reach Of Children

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

For adults and children two-years or older: Apply to affected area not more than 3 or 4 times
daily. Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate,
Emu Oil, Ethoxydiglycol, Ethylhexyglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7,
Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol,Polyacrylamide, Propylene Glycol,StearicAcid,Triethanolamine.

Other Information

Protect this product from excessive heat and direct sun.

Product Label

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