ASPIERA ANTI-FUNGAL - clotrimazole ointment
Aidance Skincare & Topical Solutions, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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 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), eucalyptus citriodora oil, magnesium oxide, silver oxide, simmondsia chinensis (jojoba) seed oil, tea tree oil, zinc oxide

Made in USA. Distributed by Aspiera Medical, a division of Aidance Skincare & Topical Solutions, LLC. (+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 Aidance Skincare (C) 2012 Aidance Skincare.

PRINCIPAL DISPLAY PANEL - 44g Jar

Aspiera

Anti-Fungal Ointment

Faster Penetration for Faster Healing™

Label Image

ASPIERA ANTI-FUNGAL
clotrimazole ointment

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (CLOTRIMAZOLE)	CLOTRIMAZOLE	1.0 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENTONITE
EUCALYPTUS OIL
JOJOBA OIL
MAGNESIUM OXIDE
SILVER OXIDE
TEA TREE OIL
WHITE WAX
ZINC OXIDE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:24909-606-44	44 g in 1 JAR	None

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	Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture, label

Revised: 05/2012 Aidance Skincare & Topical Solutions, LLC