Clotrimazole Solution

Clotrimazole Solution
SPL v8
SPL
SPL Set ID d6e95c99-e055-436a-8ee6-40d6e199eaca
Route
TOPICAL
Published
Effective Date 2020-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Polyethylene Glycol 400

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-12-01

Description

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

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

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

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

Section 42229-5

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

Section 50744-2

keep this carton for important information.

Manufactured for and Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

ϯ All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Lotrimin®AF.

Rev. 11/18 IT

Warnings

For external use only

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

Active Ingredient

Clotrimazole USP, 1%

Other Information
  • Store at 15° to 30°C (59° to 86°F)
Inactive Ingredient

polyethylene glycol

Ask A Doctor Before Use

on children under 2 years of age

Principal Display Panel

Rev. 01/20 IT

NDC 10135-0671-91

Clotrimazole

Topical Solution

USP, 1 %

30 mL

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.

Principal Display Panel 10 Ml Bottle Carton

Rev. 11/18 IT

NDC 10135-0671-81

Clotrimazole

Topical Solution

USP, 1 %

10 mL


Structured Label Content

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

Section 42229-5 (42229-5)

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

Section 50744-2 (50744-2)

keep this carton for important information.

Manufactured for and Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

ϯ All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Lotrimin®AF.

Rev. 11/18 IT

Purpose

Antifungal

Warnings

For external use only

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

Active Ingredient (Active ingredient)

Clotrimazole USP, 1%

Other Information (Other information)
  • Store at 15° to 30°C (59° to 86°F)
Inactive Ingredient (Inactive ingredient)

polyethylene glycol

Ask A Doctor Before Use (Ask a doctor before use)

on children under 2 years of age

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Rev. 01/20 IT

NDC 10135-0671-91

Clotrimazole

Topical Solution

USP, 1 %

30 mL

When Using This Product (When using this product)

avoid contact with eyes

Stop Use and Ask A Doctor If (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 (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel 10 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton)

Rev. 11/18 IT

NDC 10135-0671-81

Clotrimazole

Topical Solution

USP, 1 %

10 mL


Advanced Ingredient Data


Raw Label Data

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