Fungi Nail Toe And Foot Solution
FDA Label NDC 55505-177
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Laboratories for the product Fungi Nail Toe And Foot (NDC 55505-177). 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 - Purpose
| Active Ingredient | Purpose |
| Tolnaftate 1% | Anti-fungal |
Indications & Usage
Uses ■ Proven effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis) ■ 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 areas with soap and warm water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail® Anti-Fungal Liquid 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. For toe fungus, apply under nail and around cuticle area. If condition persists longer, consult a doctor. ■ 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 controlled room temperature 15°-30° C (59°-86° F) Protect from freezing. If freezing occurs warm to room temperature.
Inactive Ingredient
Inactive ingredients
Aloe Vera Leaf, Benzoic Acid, Caprylyl Glycol, Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked), Citric Acid, Dimethicone 350, Ethylhexyl Glycerin, Eucalyptol, Glycerin, Glyceryl Monostearate, Lavender Oil, Olive Oil, Phenoxyethanol, Poloxamer 188, Purified Water USP, Sodium Hydroxide, Tea Tree Oil, Triethyl Citrate
Principal Display Panel
NEW Improved Formula
MAXIMUM STRENGTH
FUNGI-NAIL®
ANTI-FUNGAL
LIQUID
CLINICALLY PROVEN TO
CURE AND PREVENT
FUNGAL INFECTIONS
TRIPLE ACTION FORMULA
✓ Kills Fungus
✓ Stops Itching & Burning
✓ Restores Skin Health
CLINICALLY PROVEN INGREDIENT
1 FL. OZ. (30mL)
Convenient and Easy to Apply
Deep Penetrating Medicine that Stays in Place
Not actual size.
Patent pending.
#1 Pharmacist Recommended
FUNGI-NAIL® ANTI-FUNGAL LIQUID infused with 5 natural oils including tea tree, eucalyptol, aloe, olive and lavender
For best results treat around all toenails and in between toes.
Not for Nail or scalp fungus.
Cures most athlete's foot.
For more information about Fungi-Nail® and money back guarantee, visit us at funginail.com
Kramer Laboratories, Inc.
Bridgewater, NJ 08807
kramerlabs.com
funginail.com
1-800-824-4894
K1118
NDC# 55505-177-26
MAXIMUM STRENGTH
FUNGI-NAIL® ANTI-FUNGAL
LIQUID
KILLS FUNGUS
RESTORES SKIN
NET WT 1 FL. OZ. (30mL)
Distributed By:
KRAMER LABORATORIES
Kramer Laboratories, Inc.
Bridgewater, NJ 08807
kramerlabs.com
fungi-nail.com
1-800-824-4894
K1118
Label (Label)
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