CLOTRIMAZOLE by Rugby Laboratories, Inc. / Sun Pharma Canada Inc. CLOTRIMAZOLE solution

CLOTRIMAZOLE by

Drug Labeling and Warnings

CLOTRIMAZOLE by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Inc., Sun Pharma Canada Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Clotrimazole USP, 1%

Purpose

Antifungal

Uses

• cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
• effectively relieves
  • itching
  • cracking
  • burning
  • discomfort which can accompany these conditions

Warnings

For external use only

Ask a doctor before use

• on children under 2 years of age.

When using this product

• avoid contact with eyes

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)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• This product is not effective on the scalp or nails
  For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
• clean 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

For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily

Other information

• Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].

Inactive ingredients

polyethylene glycol 400

Questions?

Call 1-866-923-4914

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Distributed by:
RUGBY ®LABORATORIES
Indianapolis, IN 46268

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

Rugby ®

NDC: 0536-1443-70
Compare to the
active ingredient in
Lotrimin ®AF*
Clotrimazole Antifungal

Clotrimazole
Topical Solution
USP, 1%
Antifungal

Cures Most
Athlete's Foot

• Relieves Itching, Burning
• Greaseless, Nonstaining

10 mL (⅓ fl oz)

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1443
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1443-70	1 in 1 CARTON	11/21/2024
1		10 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	11/21/2024

Labeler - Rugby Laboratories, Inc. (079246066)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharma Canada Inc.		243339023	manufacture(0536-1443)