Antifungal Liquid — v1

Antifungal Liquid

9 Views

Version

v1

Effective date

October 1, 2025

Original packager

Yes

Sections captured

15

Identifiers

Document ID
401f4abd-c1a0-a86b-e063-6394a90ace7c
Set ID
401f4993-0200-f1fd-e063-6294a90a6589
Application numbers
M005
Product NDCs
79903-394
Package NDCs
79903-394-01
Original packager NDCs
—

Names & Manufacturers

Brand names
Antifungal Liquid
Generic names
TOLNAFTATE
Manufacturer names
Wal-Mart Stores, Inc.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
TOLNAFTATE
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
—
UNII
06KB629TKV
UPC
0194346565849

Structured Label Sections

Active Ingredient (1)

Sequence 1

​Active ingredient Tolnaftate 1%
Do Not Use (1)

Sequence 1

Do not use on children under 2 years of age unless directed by a doctor.
Dosage And Administration (1)

Sequence 1

​Directions clean the affected area and dry thoroughly apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily for athlete's foot and ringworm, use daily for 4 weeks. if condition persists longer, consult a doctor to prevent athlete's foot: wash the feet and dry thoroughly; apply a thin layer of the product to the feet once or twice daily (morning and/or night) this product is not effective on the scalp or nails
Inactive Ingredient (1)

Sequence 1

​Inactive ingredient Acetone, Propylene Glycol,Tocopheryl Acetate, Water
Indications And Usage (1)

Sequence 1

Uses proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) prevents the recurrence of most athlete's foot with daily use for effective relief of itching, burning, cracking, redness and scaling
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.
Other Safety Information (1)

Sequence 1

​Other information ​ SHAKE WELL BEFORE USE store at room temperature 15°-30°C (59° - 86°F) protect from freezing; if freezing occurs, warm to room temperature keep tightly closed when not in use
Package Label Principal Display Panel (1)

Sequence 1

Principal Display Panel equate MAXIMUM STRENGTH Antifungal Liquid Tolnaftate 1% / Antifungal Proven clinically effective in the treatement of fungus on fingers, toes, and skin around nails Prevents the recurrence of most athlete's foot with daily use Relieves itching, burning & scaling Built-in brush for easy application With moisturizing ingredients 1 FL OZ (30 mL) carton
Purpose (1)

Sequence 1

​Purpose Antifungal
Questions (1)

Sequence 1

Questions? Call 1-866-964-0939
Recent Major Changes (1)

Sequence 1

.
Spl Product Data Elements (1)

Sequence 1

Antifungal Liquid Tolnaftate ALPHA-TOCOPHEROL ACETATE TOLNAFTATE TOLNAFTATE WATER ACETONE PROPYLENE GLYCOL
Stop Use (1)

Sequence 1

Stop use and consult a doctor if irritation occurs there is no improvement within 4 weeks
Warnings (1)

Sequence 1

Warnings For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with the eyes. Stop use and consult a doctor if irritation occurs there is no improvement within 4 weeks Keep out of reach of children. If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.
When Using (1)

Sequence 1

When using this product avoid contact with the eyes.

OpenFDA raw payload

{'application_number': ['M005'],
 'brand_name': ['Antifungal Liquid'],
 'generic_name': ['TOLNAFTATE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Wal-Mart Stores, Inc.'],
 'package_ndc': ['79903-394-01'],
 'product_ndc': ['79903-394'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['401f4abd-c1a0-a86b-e063-6394a90ace7c'],
 'spl_set_id': ['401f4993-0200-f1fd-e063-6294a90a6589'],
 'substance_name': ['TOLNAFTATE'],
 'unii': ['06KB629TKV'],
 'upc': ['0194346565849']}