Remedy Nails Lotion
FDA Label NDC 72222-224

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Adwill Labs Inc for the product Remedy Nails (NDC 72222-224). 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:, otc - keep out of reach of children, stop use and ask a doctor if:, directions:, caution:, allergic reactions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient:

Undecylenic Acid USP 10%

Purpose:

Anti-Fungal

Uses:

Treats cuticle and skin fungal infections.

  • Heals and moisturizes cuticles and skin.
  • Athlete's foot treatment.
  • Relieves itching, burning and cracking.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

  • Consult your doctor if you are pregnant before using this product.
  • It is not known whether this drug passes into breast milk.
  • Consult your doctor before breast feeding.
  • If swallowed, call Poison Control Center immediately.

Stop Use And Ask A Doctor If:

Irritation occurs.

  • No improvement within 2 weeks.

Directions:

Wash and dry affected area.

  • Apply a thin layer over affected area twice daily or as directed by a doctor.
  • Apply enough medication to cover the affected area and surrounding skin.
  • Wash hands after use.
  • For maximum results, use twice daily or as instructed.
  • Discontinuing use of this medication may allow recurrence of infection.
  • If condition persists, consult your doctor.

Caution:

Do not accept if safety seal is broken or missing.

  • Store at room temperature 60-85F.
  • Keep in tight, light resistant container.

Allergic Reactions:

Contact doctor if unusual reactions to this medicine occur.

  • This product does not contain FD&C Yellow #5 or FD&C Yellow #6.

Inactive Ingredients:

Mineral Oil, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Oil, Linalool, Carthamus Tinctorius (Safflower) Seed Oil, Limonene, Aleurites Moluccana (Kukui) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Algae Extract.

Principal Display Panel - 15 Ml Bottle Label

Dr.'s REMEDY®
Therapeutic Cuticle Oil

Lavender
Safflower
Tea Tree Oil
Algae Extract

Nourishing
Anti-Fungal
Treatment

15mL

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