Fungi Nail Toe And Foot Ointment
FDA Label NDC 72667-346

13 label sections · Submitted to the FDA by Inspec Solutions · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Inspec Solutions for the product Fungi Nail Toe And Foot (NDC 72667-346). 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 - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient


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 useon children under 2 years of age unless directed by a doctor.

Otc - When Using

When using this productavoid 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 warm water and dry thoroughly.
  • Apply a thin layer of Fungi-Nail® Anti-Fungal Ointment over affected area twice daily (morning and night) or as directed by a doctor.
  • 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).
  • This 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.
  • Keep carton for full product information.

Inactive Ingredient

Inactive ingredients 3-O-ethyl ascorbic acid, aloe barbadensis leaf juice, cinnamomum zeylanicum bark oil, citric acid, cocos nucifera (coconut) oil, dimethicone, disodium EDTA, DMDM hydantoin, eucalyptol, eugenia caryophyllus (clove) leaf oil, glycerin, glyceryl stearate SE, lavandula angustifolia (lavender) oil, melaleuca alternifolia (tea tree) leaf oil, mineral oil, olea europaea (olive) fruit oil, PEG-100 stearate, phenoxyethanol, potassium sorbate, propylene glycol, sodium benzoate, thymus vulgaris (thyme) oil, titanium dioxide, tocopheryl acetate, water, xanthan gum.

Questions?

1-800-824-4894

Principal Display Panel

MAXIMUM STRENGTH

FUNGI-NAIL ®
ANTI-FUNGAL
OINTMENT

with brush applicator

CLINICALLY PROVEN TO
CURE AND PREVENT
FUNGAL INFECTIONS

TRIPLE ACTION FORMULA
✓ Kills Fungus
✓ Stops Itching & Burning
✓ Restores Skin Health
   + Cures Most Athlete's Foot

CLINICALLY PROVEN INGREDIENT

PLUS
Aloe & Tea Tree Oil

NET WT 0.7 OZ (20 g)

Not actual size.

New Formula

FUNGI-NAIL ®
Maximum Strength
Anti-Fungal plus9 natural oils:

○ aloe vera
○ tea tree
○ coconut
○ lavender
○ olive
○ thyme
○ cloves
○ cinnamon
○ eucalyptol

andantioxidant
Vitamin E

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

Fungi-Nail® is Specially Formulated to
Kill Fungus and Restore Skin Health
Deep Penetrating Medicine that Stays in Place
Convenient & Easy to Apply

Kramer Laboratories, Inc.,Bridgewater, NJ 08807 1-800-824-4894
For best results treat skin around all toenails and in between toes.
Not for nail or scalp fungus. Cures most athlete’s foot.

K0126

Carton Label (Cartonlabel)

Carton Label (Cartonlabel)

* Please review the disclaimer below.