1. Home
  2. Labeler Index
  3. Convatec, Inc.
  4. 43553-3251
  5. Label Information: Aloe Vesta Antifungal

FDA Label for Aloe Vesta Antifungal

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE ON
    6. WHEN USING THIS PRODUCT,
    7. IF IRRITATION OCCURS
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL DISPLAY PANEL

Aloe Vesta Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product Convatec, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 - 3cc7fd25 d33f 41ea 8f0c 49402a01e386 01

Aloe Vesta Antifungal Ointment Label - 3cc7fd25 d33f 41ea 8f0c 49402a01e386 01

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


* Please review the disclaimer below.