Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID d1e56f5f-3665-420c-9753-6c1c38ba112f
Route
TOPICAL
Published
Effective Date 2010-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 mL)
Inactive Ingredients
Butane Panthenol Propane Propylene Glycol Avocado

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-09-01
Description

Active Ingredient Clotrimazole 1%

Medication Information

Warnings and Precautions
Warnings  

  • For external use only  
  • Do not use on children under 2 years of age unless directed by a doctor 
  • For external use only   
  • Avoid spraying into the eyes
Indications and Usage
Use  

  • For the cure of most athlete’s foot (tinea pedis)

  • ringworm (tinea corporis)
Dosage and Administration

Directions

  • Clean the affected area and dry thoroughly 
  • Hold can upright
  • Shake can well before each use  
  • Spray a thin layer of the product over the 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 and ringworm, use daily for 4 weeks

  • If condition persists longer, consult a doctor
Description

Active Ingredient Clotrimazole 1%

Section 42229-5
Caution :
  • Contents are under pressure
  • Protect from direct sunlight and do not store at temperatures above 120F/50C
  • After use, do not puncture or incinerate container
  • Spray only in a well ventilated area
  •  Do not spray in presence of open flame or spark or while smoking

Section 50565-1
Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately.
Section 50566-9
Stop use and ask a doctor if
  • irritation occurs or if there is no improvement within 4 weeks
Section 51727-6
I n active Ingredients   Butane, Panthenol, Propylene Glycol, (and) Persea Gratissima (Avocado) Fruit Extract, SD Alcohol 40-B, Undecylenamide DEA
Section 51945-4
Package label



Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Purpose

Antifungal
Section 55106-9
Active Ingredient

Clotrimazole 1%

Structured Label Content

Indications and Usage (34067-9)
Use  

  • For the cure of most athlete’s foot (tinea pedis)

  • ringworm (tinea corporis)
Dosage and Administration (34068-7)

Directions

  • Clean the affected area and dry thoroughly 
  • Hold can upright
  • Shake can well before each use  
  • Spray a thin layer of the product over the 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 and ringworm, use daily for 4 weeks

  • If condition persists longer, consult a doctor
Warnings and Precautions (34071-1)
Warnings  

  • For external use only  
  • Do not use on children under 2 years of age unless directed by a doctor 
  • For external use only   
  • Avoid spraying into the eyes
Section 42229-5 (42229-5)
Caution :
  • Contents are under pressure
  • Protect from direct sunlight and do not store at temperatures above 120F/50C
  • After use, do not puncture or incinerate container
  • Spray only in a well ventilated area
  •  Do not spray in presence of open flame or spark or while smoking

Section 50565-1 (50565-1)
Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately.
Section 50566-9 (50566-9)
Stop use and ask a doctor if
  • irritation occurs or if there is no improvement within 4 weeks
Section 51727-6 (51727-6)
I n active Ingredients   Butane, Panthenol, Propylene Glycol, (and) Persea Gratissima (Avocado) Fruit Extract, SD Alcohol 40-B, Undecylenamide DEA
Section 51945-4 (51945-4)
Package label



Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Purpose

Antifungal
Section 55106-9 (55106-9)
Active Ingredient

Clotrimazole 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:07.833270 · Updated: 2026-03-14T22:52:28.188101