FDA Label for Rugby Antifungal Clotrimazole
View Indications, Usage & Precautions
Rugby Antifungal Clotrimazole Product Label
The following document was submitted to the FDA by the labeler of this product Rugby. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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Drug Facts
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RUGBY® LABORATORIES
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
Active Ingredient
Clotrimazole 1%
Purpose
Antifungal
Uses
- cures most athlete's foot, jock itch, and ringworm
- relieves itching, burning, cracking, scaling and discomfort
Warnings
For external use only.
Avoid contact with eyes.
Otc - Do Not Use
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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
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 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
Questions Or Comments?
1-800-645-2158
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)
* Please review the disclaimer below.