RUGBY ANTIFUNGAL CLOTRIMAZOLE
RUGBY ANTIFUNGAL CREAM CLOTRIMAZOLE 1%
0b32a369-ea1c-4cb8-8ea1-07bba8f16b72
HUMAN OTC DRUG LABEL
Sep 16, 2025
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
Product Classification
Product Specifications
INGREDIENTS (15)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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)
INDICATIONS & USAGE SECTION
Uses
▪
cures most athlete's foot, jock itch, and ringworm
▪
relieves itching, burning, cracking, scaling and discomfort
SPL UNCLASSIFIED SECTION
Distributed by:
RUGBY**®**** LABORATORIES**
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Clotrimazole 1%
OTC - PURPOSE SECTION
Purpose
Antifungal
WARNINGS SECTION
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
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
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
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
Questions or comments?
1-800-645-2158