CVS Pharmacy Athletes Foot — v7

CVS Pharmacy Athletes Foot

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Version

v7

Effective date

September 25, 2025

Original packager

Yes

Sections captured

16

Identifiers

Document ID
3fa1720b-847a-ab0a-e063-6394a90a1e78
Set ID
98a4ed66-2813-49de-8cda-94c41cc3ca9f
Application numbers
ANDA077511
Product NDCs
59779-080
Package NDCs
59779-080-01, 59779-080-02
Original packager NDCs
—

Names & Manufacturers

Brand names
CVS Pharmacy Athletes Foot
Generic names
TERBINAFINE HYDROCHLORIDE
Manufacturer names
CVS Pharmacy
Product types
HUMAN OTC DRUG

Substances & Pharmacology

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

Other identifiers

NUI
—
RxCUI
992528
UNII
012C11ZU6G
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Terbinafine hydrochloride 1%
Do Not Use (1)

Sequence 1

Do not use on nails or scalp in or near the mouth or eyes for vaginal yeast infections
Dosage And Administration (1)

Sequence 1

Directions adults and children 12 years and over: use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor wash hands after each use children under 12 years: ask a doctor image
Dosage And Administration Table (1)

Sequence 1

adults and children 12 years and over: use the tip of the cap to break the seal and open the tubewash the affected skin with soap and water and dry completely before applyingfor athlete's footwear well-fitting, ventilated shoes. Change shoes and socks at least once daily. between the toes only: apply twice a day (morning and night) for 1 weekor as directed by a doctor on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeksor as directed by a doctor for jock itch and ringworm:apply once a day (morning ornight) for 1 weekor as directed by a doctor wash hands after each usechildren under 12 years: ask a doctor
Inactive Ingredient (1)

Sequence 1

Inactive ingredients benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol
Indications And Usage (1)

Sequence 1

Uses cures most athlete's foot (tinea pedis) cures most jock itch (tinea cruris) and ringworm (tinea corporis) relieves itching, burning, cracking and scaling which accompany these conditions
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton CVS Health ® Compare to the active ingredient in Lamisil AT® * NDC 59779-080-01 Full Prescription Strength Athlete's Foot Cream TERBINAFINE HYDROCHLORIDE CREAM, 1% Antifungal Clinically proven to cure most athlete's foot between the toes Relieves itching Package Contains One Tube NET WT 0.5 OZ (15 g) PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
Purpose (1)

Sequence 1

Purpose Antifungal
Questions (1)

Sequence 1

Questions? call 1-866-923-4914
Spl Product Data Elements (1)

Sequence 1

CVS Pharmacy Athletes Foot Terbinafine Hydrochloride ISOPROPYL MYRISTATE POLYSORBATE 60 WATER SODIUM HYDROXIDE SORBITAN MONOSTEARATE STEARYL ALCOHOL TERBINAFINE HYDROCHLORIDE TERBINAFINE BENZYL ALCOHOL CETYL ALCOHOL CETYL PALMITATE
Spl Unclassified Section (2)

Sequence 1

Drug Facts

Sequence 2

Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895
Stop Use (1)

Sequence 1

Stop use and ask a doctor if too much irritation occurs or gets worse
Storage And Handling (1)

Sequence 1

Other information TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE. store at controlled room temperature 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date
Warnings (1)

Sequence 1

Warnings For external use only Do not use on nails or scalp in or near the mouth or eyes for vaginal yeast infections When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if too much irritation occurs or gets worse Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
When Using (1)

Sequence 1

When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water.

OpenFDA raw payload

{'application_number': ['ANDA077511'],
 'brand_name': ['CVS Pharmacy Athletes Foot'],
 'generic_name': ['TERBINAFINE HYDROCHLORIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['CVS Pharmacy'],
 'package_ndc': ['59779-080-01', '59779-080-02'],
 'product_ndc': ['59779-080'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'rxcui': ['992528'],
 'spl_id': ['3fa1720b-847a-ab0a-e063-6394a90a1e78'],
 'spl_set_id': ['98a4ed66-2813-49de-8cda-94c41cc3ca9f'],
 'substance_name': ['TERBINAFINE HYDROCHLORIDE'],
 'unii': ['012C11ZU6G']}