Drug Facts

ALOE VESTA ANTIFUNGAL  - miconazole nitrate ointment 
ConvaTec, Inc.

----------

Drug Facts

Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

Warnings

For external use only.

Do not use on

children under 2 years of age unless directed by a physician.

When using this product,

avoid contact with eyes.

If irritation occurs

or if there is no improvement within 2 weeks for jock itch, or 4 weeks for athlete's foot or ringworm, discontinue use and consult a physician.

Keep out of reach of children.

If swallowed, get medical help or consult a Poison Control Center right away.

Directions

Clean the affected area and dry thoroughly.

For athlete's foot:  Pay close attention to spaces between the 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.

For jock itch:  use daily for 2 weeks

Other Information

Store at 15oC - 30oC (59oF - 86oF).

Inactive Ingredients

Aloe Extract, Light Mineral Oil, Softisan 649, White Petrolatum.

PRINCIPAL DISPLAY PANEL

Aloe Vesta Antifungal Ointment Label

NDC 43553-3251-2

ConvaTec

ALOE VESTATM

Antifungal Ointment

TREAT

Miconazole Nitrate 2%

CURES MOST:

Athlete's Foot

Ringworm

Jock Itch

Superficial Yeast Infections

NET WT. 2oz.(56g)

CSX0647A Case Order No. 325102


ALOE VESTA ANTIFUNGAL 
miconazole nitrate   ointment
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)43553-3251
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
LIGHT MINERAL OIL 
PETROLATUM 
Product Characteristics
Colorwhite (white to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
143553-3251-256 g In 1 TUBENone
243553-3251-5141 g In 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/03/1997

Labeler - ConvaTec, Inc. (947989757)
Registrant - ConvaTec, Inc. (947989757)
Establishment
NameAddressID/FEIOperations
Guest Packaging LLC001773076manufacture
Establishment
NameAddressID/FEIOperations
Medicia091396697manufacture
Establishment
NameAddressID/FEIOperations
ConvaTec, Inc.831497172analysis
Revised: 06/2010ConvaTec, Inc.