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Name:Aloe Vesta Antifungal
Manufacturer:Convatec, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

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

  • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort that accompany these conditions.
  • For the treatment of most superficial skin infections caused by yeast (Candida albicans).
  • Follow a physician's instructions when treating Candida.

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.

  • Apply a thin layer of ointment over affected area twice daily (morning and night) or as directed by a physician.
  • Supervise children in use of this product. 
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
  • If condition persists longer, consult a physician.
  • This product is not effective on the scalp or nails.

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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 20 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF  
LIGHT MINERAL OIL  
PETROLATUM  
Product Characteristics
Color white (white to off-white) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43553-3251-2 56 g in 1 TUBE None
2 NDC:43553-3251-5 141 g in 1 TUBE None

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 Operations
Guest Packaging LLC 001773076 manufacture
Establishment
Name Address ID/FEI Operations
Medicia 091396697 manufacture
Establishment
Name Address ID/FEI Operations
ConvaTec, Inc. 947989757 analysis

Revised: 04/2011 ConvaTec, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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