Clotrimazole Solution

Clotrimazole Solution

Drug Labeling and Warnings

Drug Details

k">

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.

----------

Clotrimazole Solution

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.

----------

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 - 10 mL Bottle Carton
NDC: <a href=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" src="https://fda.report/DailyMed/d6e95c99-e055-436a-8ee6-40d6e199eaca/clotrimazole-solution-01.jpg&archiveid=359821"/>

CLOTRIMAZOLE 
clotrimazole solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10135-671
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10135-671-811 in 1 CARTON12/01/2018
110 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C12/01/2018
Labeler - Marlex Pharmaceuticals Inc (782540215)

Revised: 12/2018
 
Marlex Pharmaceuticals Inc


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.