Clotrimazole by Marlex Pharmaceuticals Inc CLOTRIMAZOLE solution

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by Marlex Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

CLOTRIMAZOLE - clotrimazole solution Marlex Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Clotrimazole Topical Solution USP,1%

Drug Facts

Active ingredient

Clotrimazole USP, 1%

Purpose

Antifungal

Uses

Cures most

• Athlete's foot (tinea pedis)
  
• Jock Itch (tinea cruris)
  
• 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 15° to 30°C (59° to 86°F)

Inactive ingredient

polyethylene glycol 400

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

NDC: 10135-0671-81

Compare to the active ingredient of Lotrimin® AF*

Clotrimazole Topical Solution USP,1%

Antifungal

• Relieves Itching & Burning
  
• Greaseless, Nonstaining

For External use only.

Not for Opthalmic use.

Keep this and all medications out of the reach of children.

Marlex Pharmaceuticals, Inc.

10mL

PRINCIPAL DISPLAY PANEL

NDC: 10135-0671-91
Clotrimazole 
Topical Solution
USP, 1 %
30 mL
Rx Only

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10135-671
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10135-671-81	1 in 1 CARTON	12/01/2018
1		10 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 10135-671-91	1 in 1 CARTON	02/01/2020
2		30 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 FINAL	part333C	12/01/2018

Labeler - Marlex Pharmaceuticals Inc (782540215)