FDA.reportPublic FDA data

Fungi Nail Toe and Foot

Manufacturer
Kramer Laboratories
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:28:27

Label at a glance#

ProductFungi Nail Toe and Foot
Active ingredientTolnaftate
Label structure11 sections

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.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientPurpose
Tolnaftate 1%Anti-fungal

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if ■ irritation occurs ■ there is no improvement within 4 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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. ■ 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. If condition persists longer, consult a doctor. ■ 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 SECTION

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 SECTION

Inactive ingredients aloe barbadensis leaf juice, benzoic acid, caprylyl glycol, carbomer, cinnamomum zeylanicum bark oil, citric acid, cocos nucifera (coconut) oil, dimethicone, ethylhexylglycerin, eucalyptol, eugenia caryophyllus (clove) leaf oil, glycerin, glyceryl stearate, lavandula hybrida grosso herb oil, melaleuca alternifolia (tea tree) leaf oil, olea europaea (olive) fruit oil, phenoxyethanol, poloxamer 188, sodium carbonate, sodium hydroxide, thymus vulgaris (thyme) oil, triethyl citrate, water.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
   * Cures Most Athlete's Foot

CLINICALLY PROVEN INGREDIENT

PLUS
Aloe & Tea Tree Oil

1 FL. OZ. (30mL)

NEW FORMULA

FUNGI-NAIL®
Maximum Strength
Anti-Fungal plus
9 natural oils:
○ aloe vera
○ tea tree
○ coconut
○ lavender
○ olive oil
○ thyme
○ cloves
○ cinnamon
○ eucalyptol

Deep Penetrating Medicine
that Stays in Place
Convenient & Easy to Apply

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

Kramer Laboratories, Inc.
Bridgewater, NJ 08807
1-800-824-4894
K0825

Not actual size.

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

Do not use if safety seal
is missing or broken

30ml Carton Liquid
30ml Carton Liquid

MAXIMUM
STRENGTH

FUNGI-NAIL®
ANTI-FUNGAL
SPRAY

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

1 FL. OZ. (30mL)

NEW FORMULA

FUNGI-NAIL®
Maximum Strength
Anti-Fungal plus
9 natural oils:
○ aloe vera
○ tea tree
○ coconut
○ lavender
○ olive oil
○ thyme
○ cloves
○ cinnamon
○ eucalyptol

Deep Penetrating Medicine
that Stays in Place
Convenient & Easy to Apply

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

Kramer Laboratories, Inc.
Bridgewater, NJ 08807
1-800-824-4894
K0825

Not actual size.

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

Do not use if safety seal is missing or broken

30ml Carton Spray
30ml Carton Spray

MAXIMUM STRENGTH

FUNGI-NAIL®
ANTI-FUNGAL
SPRAY

CLINICALLY PROVEN TO
CURE AND PREVENT
FUNGAL INFECTIONS

1 FL OZ (30mL)

Distributed by:
KRAMER
LABORITORIES
K0622

Kramer Laboratories, Inc. Bridgewater, NJ 08807
kramerlabs.com funginal.com 1-800-824-4894

Label 55505-177-80
Label 55505-177-80

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
   * Cures Most Athlete's Foot

CLINICALLY PROVEN INGREDIENT

PLUS
Aloe & Tea Tree Oil

0.5 FL. OZ. (15mL)

NEW FORMULA

FUNGI-NAIL®
Maximum Strength
Anti-Fungal plus
9 natural oils:
○ aloe vera
○ tea tree
○ coconut
○ lavender
○ olive oil
○ thyme
○ cloves
○ cinnamon
○ eucalyptol

Deep Penetrating Medicine
that Stays in Place
Convenient & Easy to Apply

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

Kramer Laboratories, Inc.
Bridgewater, NJ 08807
1-800-824-4894
K0825

Not actual size.

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

Do not use if safety seal
is missing or broken

15mL Carton Liquid
15mL Carton Liquid

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2120579FUNGI-NAIL 1 % Topical Solution, Reformulated Mar 2019PSN7
313423tolnaftate 1 % Topical SolutionPSN7
2120579tolnaftate 10 MG/ML Topical Solution [Fungi-Nail Reformulated Mar 2019]SBD7
313423tolnaftate 10 MG/ML Topical SolutionSCD7
2120579Fungi-Nail Reformulated Mar 2019 1 % Topical SolutionSY7
2120579Fungi-Nail Reformulated Mar 2019 10 MG/ML Topical SolutionSY7
313423tolnaftate 1 % Topical SolutionSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55505-177-24Fungi Nail Toe and Foot1 in 1 CARTONSOLUTION17
55505-177-24Fungi Nail Toe and Foot15 mL in 1 BOTTLE, WITH APPLICATORSOLUTION157
55505-177-26Fungi Nail Toe and Foot1 in 1 CARTONSOLUTION17
55505-177-26Fungi Nail Toe and Foot30 mL in 1 BOTTLE, WITH APPLICATORSOLUTION307
55505-177-80Fungi Nail Toe and Foot1 in 1 CARTONSOLUTION17
55505-177-80Fungi Nail Toe and Foot30 mL in 1 BOTTLE, SPRAYSOLUTION307
55505-177-87Fungi Nail Toe and Foot2 in 1 PACKAGESOLUTION27
55505-177-87Fungi Nail Toe and Foot1 in 1 CARTONSOLUTION17

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55505-17755505-177-26, 55505-177-80, 55505-177-24, 55505-177-87

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
Tolnaftate06KB629TKVACTIB
Aloe Vera LeafZY81Z83H0XIACT
Benzoic Acid8SKN0B0MIMIACT
Caprylyl Glycol00YIU5438UIACT
Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked)F68VH75CJCIACT
Cinnamomum Massoy Bark Oil16QDH8U485IACT
Citric Acid Monohydrate2968PHW8QPIACT
Cocos Nucifera Whole245J88W96LIACT
Dimethicone 3502Y53S6ATLUIACT
Ethylhexylglycerin147D247K3PIACT
EucalyptolRV6J6604TKIACT
Eugenia Uniflora LeafV95498M2O6IACT
GlycerinPDC6A3C0OXIACT
Glyceryl Monostearate230OU9XXE4IACT
Lavender OilZBP1YXW0H8IACT
Tea Tree OilVIF565UC2GIACT
Olive Oil6UYK2W1W1EIACT
PhenoxyethanolHIE492ZZ3TIACT
Poloxamer 188LQA7B6G8JGIACT
Sodium Carbonate45P3261C7TIACT
Sodium Hydroxide55X04QC32IIACT
ThymeCW657OBU4NIACT
Triethyl Citrate8Z96QXD6UMIACT
Water059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fungi Nail Toe and FootTOLNAFTATEKramer Laboratoriesa3ae043b-dc97-449b-b099-70bdf8e924822025-12-19WarningsExact identifier
ndc (package): 55505-177-80
ndc (package): 55505-177-87
ndc (package): 55505-177-26
ndc (package): 55505-177-24
ndc (product): 55505-177
ndc11 (package): 55505017724
ndc11 (package): 55505017780
ndc11 (package): 55505017726
ndc11 (package): 55505017787
spl id: 29be9a78-384b-4807-ab8b-1417d6e0e48f
spl set id: a3ae043b-dc97-449b-b099-70bdf8e92482

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.