MedPath

RUGBY ANTIFUNGAL CLOTRIMAZOLE

RUGBY ANTIFUNGAL CREAM CLOTRIMAZOLE 1%

Approved
Approval ID

0b32a369-ea1c-4cb8-8ea1-07bba8f16b72

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 16, 2025

Manufacturers
FDA

Rugby Laboratories

DUNS: 079246066

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 Code0536-1272
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
CLOTRIMAZOLE
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 16, 2025
FDA Product Classification

INGREDIENTS (15)

CLOTRIMAZOLEActive
Quantity: 0.01 g in 1 g
Code: G07GZ97H65
Classification: ACTIB
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
DMDM HYDANTOINInactive
Code: BYR0546TOW
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
EDETATE TRISODIUMInactive
Code: 420IP921MB
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/16/2025

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Rugby®

NDC 0536-1272-22

Compare to the
active ingredient
of Lotrimin AF®*

Antifungal Cream
Clotrimazole 1%

Cures most athlete's foot

NET WT 1 OZ (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/16/2025

Uses

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

relieves itching, burning, cracking, scaling and discomfort

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/16/2025

Distributed by:
RUGBY**®**** LABORATORIES**
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/16/2025

Active ingredient

Clotrimazole 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/16/2025

Purpose

Antifungal

WARNINGS SECTION

LOINC: 34071-1Updated: 9/16/2025

Warnings

For external use only.

Avoid contact with eyes.

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

Stop use and ask a doctor if

irritation occurs

there is no improvement within 4 weeks for athlete's foot and ringworm or 2 weeks for jock itch

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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/16/2025

Directions

wash affected area and dry thoroughly

apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor

supervise children in 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, consult a doctor

this product is not effective on scalp or nails

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/16/2025

Other information

store at 15 to 30°C (59 to 86°F)

**Tamper Evident:** DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/16/2025

Inactive ingredients

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/16/2025

Questions or comments?

1-800-645-2158

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.