CLOTRIMAZOLE- clotrimazole solution 
Marlex Pharmaceuticals Inc

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Clotrimazole Solution

CLOTRIMAZOLE -clotrimazolesolutionMarlexPharmaceuticals, 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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ClotrimazoleTopical Solution USP,1%

Drug Facts

Active ingredient

Clotrimazole USP, 1%

Purpose

Antifungal

Uses

Cures most

Effectively relieves

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

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

Inactive ingredient

polyethylene glycol 400

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

NDC 10135-0671-81

Compare to the active ingredient of Lotrimin ®AF*

ClotrimazoleTopical Solution USP,1%

Antifungal

For External use only.

Not for Opthalmic use.

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

MarlexPharmaceuticals, Inc.

10mL

671-81

PRINCIPAL DISPLAY PANEL

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

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

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
2NDC:10135-671-911 in 1 CARTON02/01/2020
230 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00512/01/2018
Labeler - Marlex Pharmaceuticals Inc (782540215)

Revised: 11/2023
Document Id: 097f079e-aba9-bcac-e063-6394a90abb5c
Set id: d6e95c99-e055-436a-8ee6-40d6e199eaca
Version: 6
Effective Time: 20231106
 
Marlex Pharmaceuticals Inc