Nail Renew Liquid
FDA Label NDC 62858-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nailrenew Corp for the product Nail Renew (NDC 62858-101). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, otc - do not use, otc - questions, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENT

TOLNAFTATE 1.0%

Otc - Purpose

PURPOSE

ANTIFUNGAL

Indications & Usage

USES

  • Helps cure most fungal nail and skin infections, including Tinea Corporis (Ringworm) and Tinea Pedis (Athlete's Foot).
  • Effectively relieves itching, burning, cracking and scaling accompanying the above conditions.

Warnings

WARNINGS

  • For external use only.
  • In case of accidental ingestion contact a physician, emergency medical care facility or poison control center.
  • Stop use and ask a physician if rash or irritation occurs.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Otc - Do Not Use

DO NOT USE

  • ON CHILDREN UNDER 2 UNLESS DIRECTED BY A DOCTOR.
  • NEAR OR IN EYES, EARS OR MOUTH.

Dosage & Administration

DIRECTIONS

  • Clean affected area with soap and warm water and dry thoroughly.
  • Apply 2-3 drops twice daily (morning & evening) to affected areas; especially around free edges of nails (under tips) and cuticles and the space around the toes.
  • Allow solution to soak into nail or skin.
  • This product is not effective on scalp or hair.
  • Application to adjacent nails is recommended to prevent the spread of the infection. Keep affected areas clean and dry throughout the day.

Inactive Ingredient

Water (Aqua), PEG-8, Glyceryl Stearate, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Propylene Glycol, Aloe Barbadensis Leaf Juce, Coco-betaine, Octoxynol-9, Cetyl Alcohol, Stearyl Alcohol, Hydroxyethylcellulose, Imidazolidinyl Urea, Benzyl Alcohol, Propylparaben, Triethanolamine

Package Label.Principal Display Panel

Nailrenew_bottlelabel_front (Nailrenew Bottlelabel Front)

Nailrenew_bottlelabel_front (Nailrenew Bottlelabel Front)

Nailrenew_bottlelabel_back-1 (Nailrenew Bottlelabel Back 1)

Nailrenew_bottlelabel_back-1 (Nailrenew Bottlelabel Back 1)

Nailrenew_bottlelabel_back-2 (Nailrenew Bottlelabel Back 2)

Nailrenew_bottlelabel_back-2 (Nailrenew Bottlelabel Back 2)

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