QC Clotrimazole Cream 1 oz ZDP 99261 (2019)

Manufacturer
Chain Drug Marketing Association Inc.
Effective date
2019-12-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:01:55

Label at a glance#

ProductQuality Choice Athletes Foot
Active ingredientCLOTRIMAZOLE
Label structure13 sections

Storage and handling

Other information store at room temperature 20-25°C (68-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Clotrimazole 1%....................................................................Antifungal

OTC - PURPOSE SECTION

Uses

  • cures most athlete's foot, jock itch, and ringworm

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

OTC - WHEN USING SECTION

When using this product, avoid contact with the eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 week (for jock itch)

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE SECTION

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer over affected twice daily (morning and night)
  • 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; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

cetostearyl alcohol, ethylparaben, glycerin, light mineral oil, propylene glycol, purified water, sodum sulfite, steareth-20, stearic-acid

DOSAGE & ADMINISTRATION SECTION

Distributed by C.D.M.A., Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

9926199261

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN2
309367clotrimazole 10 MG/ML Topical CreamSCD2
309367clotrimazole 1 % Topical CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-610-282022-01-28C16284748780-1d6a99b39-9f2b-a426-e053-dadaa90af4c2QC Clotrimazole Cream 1 oz ZDP 99261 (2019)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-610-28Quality Choice Athletes Foot1 in 1 CARTONCREAM12
63868-610-28Quality Choice Athletes Foot28 g in 1 TUBECREAM282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-610QUALITY CHOICE ATHLETES FOOT (CLOTRIMAZOLE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC.]2Legacy NDC, 2 package rows20191211_8d5bd5be-604d-04e9-e053-2995a90af587.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-610-28GM - Gram63868-6100b964a23-75dd-4df7-bd38-65048881920c12021-05-05

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-61063868-610-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
996027b9-3196-49eb-e053-2a95a90a018e8d5bd5be-604d-04e9-e053-2995a90af5872019-12-10WarningsExact identifier
spl id: 996027b9-3196-49eb-e053-2a95a90a018e
spl set id: 8d5bd5be-604d-04e9-e053-2995a90af587

Reported adverse events (FAERS/openFDA)#

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