Clotrimazole Solution

Clotrimazole Solution
SPL v1
SPL
SPL Set ID 3ca3b475-7b69-442a-e063-6294a90a7b3f
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 2025-08-18

Description

Clotrimazole USP, 1% (Topical Solution)

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole USP, 1% (Topical Solution)

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 USP, 1%

(Topical Solution)

Section 50744-2

Manufactured For:

AvKARE

Pulaski, TN 38478

www.avkare.com

1-855-361-3993

Rev. 05/25

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 400

Ask A Doctor Before Use

on children under 2 years of age

Principal Display Panel

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 THE 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 30 Ml Bottle Carton


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 USP, 1%

(Topical Solution)

Section 50744-2 (50744-2)

Manufactured For:

AvKARE

Pulaski, TN 38478

www.avkare.com

1-855-361-3993

Rev. 05/25

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 400

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

on children under 2 years of age

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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 THE REACH OF CHILDREN.

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 30 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton)


Advanced Ingredient Data


Raw Label Data

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