Ariella Nail Repair Pen
FDA Label NDC 83364-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Yitongbada (shenzhen) International Trade Co., Ltd for the product Ariella Nail Repair Pen (NDC 83364-001). 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, uses, warnings, directions, other information, inactive ingredients, questions or comments?, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                               Purpose

Chitosan   2%                                  Anti-fungal

Salicylic Acid   3%                            Anti-fungal

Uses

Treatment of fingernail and toenail fungus

Warnings

For external use only.

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes.

Stop and ask a doctor if - irritation occurs - there is no improvement within 4 weeks

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

Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

Directions

  • Soak your feet in hot water for 5 minutes, then dry your toes.
  • Use a nail cutter and file (not included) to trim nails that need repair so that the liquid can soak in better.
  • Gently turn the end of the pen to dispense treatment liquid onto the brush applicator.
  • Apply the liquid over the areas that need to be repaired, and make sure to cover all affected parts.
  • Use daily for 2-4 weeks, according to the condition of the area that needs repair.
  • Recommended use: 2-3 times a day.

Other Information

store at 15-28°C (59.0-82.4°F)

Inactive Ingredients

Aqua, Sorbitol, Alcohol, Propylene Glycol, Angelica Dahurica Extract,Chlorhexidine Diacetate, Laurocapram, Caramel

Product Label

Image Description (Image 1)

Image Description (Image 1)

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