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CVS Pharmacy

Clotrimazole · Cream

Over-the-counter NDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
CVS Pharmacy Clotrimazole 3
Generic name
Clotrimazole
Dosage form
Cream
Route
Vaginal
Marketing category
NDA · NDA
Labeler
CVS Pharmacy
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
5
NDC product codes
4
Packages
5
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
Benzalkonium Chloride .0013 g/g 1020365 —
Benzocaine .05 g/g 238910 —
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
Vaginal
Presentations
9

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
Allergens [CS] CS 2 members — no class page
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
Cell-mediated Immunity [PE] PE 2 members — no class page
Increased Histamine Release [PE] PE 2 members — no class page
Standardized Chemical Allergen [EPC] EPC 1 member — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
021143
Application type
NDA · New Drug Application
Approval date
April 12, 2000
Sponsor
SUN PHARMA CANADA
Products on application
1
Submissions recorded
8
Products approved under application 021143.
Product Trade name Form Strength Ingredient Status TE Flags
021143-001 TRIVAGIZOLE 3 CREAM CLOTRIMAZOLE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 021143.
Type No. Action Status Date Review
Supplement 12 Labeling Approved August 25, 2016 Standard
Supplement 11 Manufacturing (CMC) Approved May 15, 2014 Standard
Supplement 5 Manufacturing (CMC) Approved December 10, 2002 Standard
Supplement 4 Manufacturing (CMC) Approved November 8, 2002 Standard
Supplement 3 Manufacturing (CMC) Approved September 17, 2001 Standard
Supplement 2 Manufacturing (CMC) Approved January 10, 2001 Standard
Supplement 1 Manufacturing (CMC) Approved October 18, 2000 Standard
Original application 1 Type 3 - New Dosage Form Approved April 12, 2000 Standard

Review documents

  • 0 · Supplement · August 25, 2016
  • 0 · Supplement · August 25, 2016
  • 0 · Original application · July 30, 2001
  • 0 · Original application · April 12, 2000
  • 0 · Original application · April 12, 2000

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250925). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250925 HUMAN OTC DRUG · 20250717

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

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 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

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 on nails or scalp in or near the mouth or eyes for vaginal yeast infections

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 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
59779-080-01 59779-080 CVS Pharmacy 1 TUBE in 1 CARTON (59779-080-01) / 15 g in 1 TUBE July 2, 2007
59779-080-02 59779-080 CVS Pharmacy 1 TUBE in 1 CARTON (59779-080-02) / 30 g in 1 TUBE July 2, 2007
59779-510-01 59779-510 CVS Pharmacy 1 TUBE in 1 CARTON (59779-510-01) / 15 g in 1 TUBE January 10, 2013
69842-062-00 69842-062 CVS Pharmacy 1 TUBE, WITH APPLICATOR in 1 CARTON (69842-062-00) / 21 g in 1 TUBE, WITH APPLICATOR August 6, 2019
69842-638-01 69842-638 CVS Pharmacy 1 TUBE in 1 CARTON (69842-638-01) / 42.5 g in 1 TUBE May 1, 2005
59779-080 59779-080 CVS Pharmacy — July 2, 2007
59779-510 59779-510 CVS Pharmacy — January 10, 2013
69842-062 69842-062 CVS Pharmacy — April 12, 2000
69842-638 69842-638 CVS Pharmacy — May 1, 2005

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.