ASPIERA ANTI-FUNGAL- clotrimazole ointment

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

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.

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.

Keep out of reach of children.

If swallowed, call poison control or seek medical help.

STOP USE

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

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

SPL UNCLASSIFIED SECTION

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.

PRINCIPAL DISPLAY PANEL - 44g Jar

Aspiera

Anti-Fungal Ointment

Faster Penetration for Faster Healing™

INGREDIENTS AND APPEARANCE

ASPIERA ANTI-FUNGAL 
clotrimazole ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-606
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SILVER OXIDE (UNII: 897WUN6G6T)
TEA TREE OIL (UNII: VIF565UC2G)
WHITE WAX (UNII: 7G1J5DA97F)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-606-44	44 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	05/31/2012

Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-606) , label(24909-606)