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  5. Label Information: Nail Renew

FDA Label for Nail Renew

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. OTC - DO NOT USE
    7. OTC - QUESTIONS
    8. DOSAGE & ADMINISTRATION
    9. INACTIVE INGREDIENT
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nail Renew Product Label

The following document was submitted to the FDA by the labeler of this product Nailrenew Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.

Otc - Questions



QUESTIONS? EMAIL: [email protected]


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


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