Aloe Vesta Antifungal
FDA Label NDC 43553-3251

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Convatec, Inc. for the product Aloe Vesta Antifungal (NDC 43553-3251). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use on, when using this product,, if irritation occurs, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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