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  5. Label Information: Fungi Nail Anti-fungal Pen

FDA Label for Fungi Nail Anti-fungal Pen

View Indications, Usage & Precautions

Table of Contents

    1. OTC - PURPOSE
    2. INDICATIONS & USAGE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - WHEN USING
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DOSAGE & ADMINISTRATION
    9. STORAGE AND HANDLING
    10. INACTIVE INGREDIENT
    11. PRINCIPAL DISPLAY PANEL

Fungi Nail Anti-fungal Pen Product Label

The following document was submitted to the FDA by the labeler of this product Kramer Laboratories. 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 - Purpose



Active IngredientPurpose
Tolnaftate 1%Anti-fungal

Indications & Usage



Uses 

  • Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of itching, burning and cracking.

Warnings



For external use only


Otc - Do Not Use



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


Otc - When Using



When using this product 

  • avoid contact with eyes.

Otc - Stop Use



Stop use and ask a doctor if 

  • irritation occurs
  • there is no improvement within 4 weeks

Otc - Keep Out Of Reach Of Children



KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.


Dosage & Administration



Directions

  • Clean affected area with soap and water and dry thoroughly.
  • Apply a thin layer of Fungi-Nail® Anti-Fungal over affected area twice daily (morning and night) or as directed by a doctor.
  • The brush applicator allows for easy application on skin around the nail and cuticle area.
  • Wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
  • For athlete's foot pay special attention to spaces between the toes.
  • For athlete's foot and ringworm, use daily for 4 weeks.
  • To prevent athlete's foot, apply once or twice daily (morning and/or night).
  • For toe fungus, apply under nail and cuticle area. If condition persists longer, consult a doctor.
  • The product is not effective on the scalp or nails.
  • Supervise children in the use of this product.

Storage And Handling



Other information Store at room temperature 15°-30°C (59°-86°F). Protect from freezing. If freezing occurs warm to room temperature.


Inactive Ingredient



Inactive ingredients aloe vera (aloe barbadensis) gel, ascorbic acid (vitamin C), dimethicone, DMDM hydantoin, edetate disodium dihydrate, eucalyptol, glycerin, glyceryl stearate SE, lavender oil, mineral oil, olive oil, PEG-100 stearate, phenoxetol, propylene glycol, tea tree oil, titanium dioxide, tocopheryl acetate (vitamin E), xanthan gum, water


Principal Display Panel



#1 Pharmacist Recommended

NEW
Improved Formula

MAXIMUM STRENGTH
FUNGI-NAIL®
ANTI-FUNGAL
PEN

CLINICALLY PROVEN TO CURE AND PREVENT  FUNGAL INFECTIONS

MAXIMUM STRENGTH
FUNGI-NAIL®

MAXIMUM STRENGTH
FUNGI-NAIL®
ANTI-FUNGAL PEN

TRIPLE ACTION FORMULA
✓ Kills Fungus
✓ Stops Itching & Burning
✓ Restores Skin Health

.101 FL OZ (3ml)

FUNGI-NAIL®
ANTI-FUNGAL
PEN

Infused with 5 natural oils including tea tree, eucalyptol, aloe vera, olive and lavender plus antioxidants Vitamin E and Vitamin C

Fungi-Nail® is Specially Formulated to Kill Fungus and Restore Skin Health

Deep Penetrating Medicine that Stays in Place
Convenient and Easy to Apply Pen Applicator

Instructions for Use:
Twist base with brush pointing downward to saturate brush (Figure1). If you do not hear a click, turn the other way. First time use may require several twists to initiate product flow. 

For best results treat around all toenails and in between toes.
Not for nail or scalp fungus. Cures most athlete's foot.

K0719

DO NOT USE IF NECKBAND IS BROKEN OR MISSING

For more information about Fungi-Nail® and money back guarantee, visit us at funginail.com

KRAMER
LABORATORIES

Kramer Laboratories, Inc.
Bridgewater, NJ 08807

kramerlabs.com • funginail.com
1-800-824-4894

TOLNAFTATE 1%

MAXIMUM STRENGTH
FUNGI-NAIL®
ANTI-FUNGAL
PEN

0.101 FL OZ
(3mL)

Directions: Clean affected area with soap and water. Dry thoroughly. Twist pen base to saturate brush, then only as needed. Do not over twist. Apply around cuticle and underneath the edge of the nail twice daily. For athlete's foot pay special attention to spaces between the toes. This product is not effective on the scalp or nails.
Keep carton for complete information.

K0719

KRAMER LABORATORIES
Kramer Laboratories, Inc.
Bridgewater, NJ 08807

kramerlabs.com
fungi-nail.com
1-800-824-4894

TWIST TOP TO BREAK SEAL OR PEEL HERE

FOR EXTERNAL USE ONLY.
DO NOT USE IF IMPRINTED SEAL ON CAP IS BROKEN, TORN OR MISSING.
 
SEALED FOR YOUR PROTECTION


* Please review the disclaimer below.