MedPath

Antifungal

Clotrimazole Cream, USP

Approved
Approval ID

5ee757e9-83eb-4829-838b-0db8fd5caa20

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Rite Aid Corporation

DUNS: 014578892

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Clotrimazole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11822-0351
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Clotrimazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (9)

CLOTRIMAZOLEActive
Quantity: 10 mg in 1 g
Code: G07GZ97H65
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
CETYL ESTERS WAXInactive
Code: D072FFP9GU
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive
Code: KH7I04HPUU
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

Package label

![Clotrimazole, USP 1%](/dailymed/image.cfm?name=clotrimazole-cream- deisted-1.jpg&id=892292)

RITE AID Jock Itch Cream Antifungal

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/12/2025

Uses

  • • cures most jock itch
  • relieves itching, burning, scaling, discomfort, and chafing associated with jock itch

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/12/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/12/2025

Active ingredient

Clotrimazole, USP 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/12/2025

Purpose

Antifungal

WARNINGS SECTION

LOINC: 34071-1Updated: 8/12/2025

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 ask a doctor if

  • irritation occurs •
  • there is no improvement within 2 weeks

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/12/2025

Directions

  • wash the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor
  • supervise children in the use of this product
  • use daily for 2 weeks
  • if condition lasts longer, ask a doctor
  • this product is not effective on the scalp or nails

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/12/2025

Other Information

  • Store between 2°-30°C (36°-86°F).
  • Before using any medication, read all label directions. Keep carton, it contains important information

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/12/2025

Inactive ingredients

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/12/2025

Questions or comments?

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Antifungal - FDA Drug Approval Details