RUGBY ANTIFUNGAL CLOTRIMAZOLE- clotrimazole cream

RUGBY ANTIFUNGAL CLOTRIMAZOLE by

Drug Labeling and Warnings

RUGBY ANTIFUNGAL CLOTRIMAZOLE by is a Otc medication manufactured, distributed, or labeled by RUGBY, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

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.

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.

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

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

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)

INGREDIENTS AND APPEARANCE

RUGBY ANTIFUNGAL CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1272
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	0.01 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETYL ALCOHOL (UNII: 936JST6JCN)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE TRISODIUM (UNII: 420IP921MB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1272-22	1 in 1 CARTON	01/14/2020
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0536-1272-11	1 in 1 CARTON	01/14/2020
2		14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/14/2020

Labeler - RUGBY (079246066)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(0536-1272)