Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 5722424d-25ef-47ce-967b-0c8daee65257
Route
TOPICAL
Published
Effective Date 2012-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1.0 g)
Inactive Ingredients
Bentonite Eucalyptus Oil Jojoba Oil Silver Oxide Tea Tree Oil Water Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-09-07

Description

Clotrimazole 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole 1%

Uses
  • Cures finger and toe area fungal infections.
  • For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort and chafing associated with fungal infection.



Section 50566-9

Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.



Section 53413-1

Questions? 877-4-AIDANCE



Warnings

For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with eyes.

Directions
  • For nail care, wash and dry affected skin. Apply a thin layer of Pedesil around and under entire nail and cuticle twice daily (morning and night) or as directed by a doctor.
  • If you see improvement within 4 weeks of use, you may continue use until satisfactory results are obtained.
  • For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks.
  • If condition persists longer, consult a doctor. Intended for use by normally healthy adults only. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor. Supervise children in the use of this product.
Active Ingredient

Clotrimazole 1%

Other Information


Store at room temperature.

Inactive Ingredients

bentonite clay, distilled water, eucalyptus citriodora oil, jojoba seed oil, silver oxide, tea tree oil, zinc oxide.





Keep Out of Reach of Children.

If swallowed, call poison control or seek medical help.

Principal Display Panel 28g Carton


Structured Label Content

Uses
  • Cures finger and toe area fungal infections.
  • For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort and chafing associated with fungal infection.



Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.



Section 53413-1 (53413-1)

Questions? 877-4-AIDANCE



Purpose

Antifungal

Warnings

For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with eyes.

Directions
  • For nail care, wash and dry affected skin. Apply a thin layer of Pedesil around and under entire nail and cuticle twice daily (morning and night) or as directed by a doctor.
  • If you see improvement within 4 weeks of use, you may continue use until satisfactory results are obtained.
  • For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks.
  • If condition persists longer, consult a doctor. Intended for use by normally healthy adults only. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor. Supervise children in the use of this product.
Active Ingredient

Clotrimazole 1%

Other Information


Store at room temperature.

Inactive Ingredients

bentonite clay, distilled water, eucalyptus citriodora oil, jojoba seed oil, silver oxide, tea tree oil, zinc oxide.





Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, call poison control or seek medical help.

Principal Display Panel 28g Carton (PRINCIPAL DISPLAY PANEL - 28g Carton)


Advanced Ingredient Data


Raw Label Data

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