ALOE VESTA ANTIFUNGAL - miconazole nitrate ointment 
ConvaTec, Inc.

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.

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:43553-3251
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
Color white (white to off-white) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43553-3251-2 56 g in 1 TUBE
2 NDC:43553-3251-5 141 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 10/03/1997
Labeler - ConvaTec, Inc. (947989757)
Registrant - ConvaTec, Inc. (947989757)
Establishment
Name Address ID/FEI Business Operations
Guest Packaging LLC 001773076 manufacture
Establishment
Name Address ID/FEI Business Operations
Medicia 091396697 manufacture
Establishment
Name Address ID/FEI Business Operations
ConvaTec, Inc. 947989757 analysis

Revised: 4/2011
Document Id: 3cc7fd25-d33f-41ea-8f0c-49402a01e386
Set id: c664e6c6-2a64-409c-9cb6-969d36fe6763
Version: 3
Effective Time: 20110408
 
ConvaTec, Inc.