drug facts

drug facts
SPL v2
SPL
SPL Set ID 3c0adc95-f8d3-4100-80d0-537bf92b56c0
Route
topical
Published
Effective Date 2012-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
clotrimazole (1.0 g)
Inactive Ingredients
bentonite jojoba oil magnesium oxide peppermint oil silver oxide tea tree oil white wax zinc oxide

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2012-05-31

Purpose

Antifungal

Description

Clotrimazole 1%


Medication Information

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.

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.
Purpose

Antifungal

Directions
  • For nail care, wash and dry affected skin. Apply a thin layer of Aspiera 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.
Other Information


Store at room temperature.

Inactive Ingredients

bentonite clay, cera alba (organic beeswax), magnesium oxide, peppermint oil, silver oxide, simmondsia chinensis (jojoba) seed oil, tea tree oil, zinc oxide

Description

Clotrimazole 1%

Section 42229-5



Made in USA. Distributed by Aspiera Medical, Woonsocket, RI 02895. (+1) 401-400-0047 www.aspiera.com

Protected by US and international patents granted and pending. Aspiera™ and Faster Penetration for Faster Healing™ are trademarks of Aspiera Medical.

Section 50566-9

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



Active Ingredient

Clotrimazole 1%

Keep Out of Reach of Children.

If swallowed, call poison control or seek medical help.

Principal Display Panel 44g Jar

Aspiera

Anti-Fungal Ointment

Faster Penetration for Faster Healing™


Structured Label Content

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.

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.
Purpose

Antifungal

Directions
  • For nail care, wash and dry affected skin. Apply a thin layer of Aspiera 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.
Other Information


Store at room temperature.

Inactive Ingredients

bentonite clay, cera alba (organic beeswax), magnesium oxide, peppermint oil, silver oxide, simmondsia chinensis (jojoba) seed oil, tea tree oil, zinc oxide

Section 42229-5 (42229-5)



Made in USA. Distributed by Aspiera Medical, Woonsocket, RI 02895. (+1) 401-400-0047 www.aspiera.com

Protected by US and international patents granted and pending. Aspiera™ and Faster Penetration for Faster Healing™ are trademarks of Aspiera Medical.

Section 50566-9 (50566-9)

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



Active Ingredient

Clotrimazole 1%

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

If swallowed, call poison control or seek medical help.

Principal Display Panel 44g Jar (PRINCIPAL DISPLAY PANEL - 44g Jar)

Aspiera

Anti-Fungal Ointment

Faster Penetration for Faster Healing™


Advanced Ingredient Data


Raw Label Data

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