Walgreens — Cream

Overview

Brand name

Walgreens Athletes Foot

Generic name

Clotrimazole

Dosage form

Cream

Route

Topical

Marketing category

ANDA · ANDA

Labeler

Walgreen Company

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

3

NDC product codes

3

Packages

4

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Clotrimazole	10 mg/g	308714	View
Clotrimazole	2 g/100g	308714	View
Terbinafine Hydrochloride	1 g/100g	992528	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Cream

Route of administration

Topical

Presentations

7

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Allylamine Antifungal [EPC]	EPC	All 11 members
Allylamine [CS]	CS	All 11 members
Azole Antifungal [EPC]	EPC	All 44 members
Azoles [CS]	CS	All 44 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

077511

Application type

ANDA · Abbreviated New Drug Application

Approval date

July 2, 2007

Sponsor

SUN PHARMA CANADA

Products on application

1

Submissions recorded

3

Products approved under application 077511.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
077511-001	TERBINAFINE HYDROCHLORIDE	CREAM		TERBINAFINE HYDROCHLORIDE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 077511.
Type	No.	Action	Status	Date	Review
Supplement	15	Labeling	Approved	February 28, 2019	Standard
Supplement	5	Manufacturing (CMC)	Approved	October 22, 2014	—
Original application	1		Approved	July 2, 2007	—

Review documents

0 · Original application · March 28, 2012

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251126). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251126 HUMAN OTC DRUG · 20250711 HUMAN OTC DRUG · 20250708

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Active ingredients Purpose Clotrimazole USP 2% (100 mg in each applicatorful) Vaginal antifungal Clotrimazole USP 2% (external cream) Vaginal antifungal

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 12 years and older 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 1 week between the toes 2 weeks on the bottom or sides of the foot Figure Figure

Warnings

openFDA Drug Labeling

Warnings For vaginal use only Do not use if you have never had a vaginal yeast infection diagnosed by a doctor Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS When using this product do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief ask a doctor before using another product Stop use and ask a doctor if symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or a foul-smelling vaginal discharge If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use

openFDA Drug Labeling

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

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or a foul-smelling vaginal discharge

Active Ingredient

openFDA Drug Labeling

Active ingredients Purpose Clotrimazole USP 2% (100 mg in each applicatorful) Vaginal antifungal Clotrimazole USP 2% (external cream) Vaginal antifungal

Adverse event reports

Source: openFDA FAERS

12,736

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: CLOTRIMAZOLE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
0363-2062-01	0363-2062	Walgreen Company	1 TUBE, WITH APPLICATOR in 1 CARTON (0363-2062-01) / 21 g in 1 TUBE, WITH APPLICATOR	April 12, 2000
0363-2080-01	0363-2080	Walgreen Company	1 TUBE in 1 CARTON (0363-2080-01) / 15 g in 1 TUBE	July 2, 2007
0363-2080-02	0363-2080	Walgreen Company	1 TUBE in 1 CARTON (0363-2080-02) / 30 g in 1 TUBE	July 2, 2007
0363-2109-01	0363-2109	Walgreen Company	1 TUBE in 1 CARTON (0363-2109-01) / 14.2 g in 1 TUBE	September 12, 2012
0363-2062	0363-2062	Walgreen Company	—	April 12, 2000
0363-2080	0363-2080	Walgreen Company	—	July 2, 2007
0363-2109	0363-2109	Walgreen Company	—	August 31, 1993

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.