ALOE VESTA CLEAR ANTIFUNGAL- miconazole nitrate ointment

Aloe Vesta Clear Antifungal by

Drug Labeling and Warnings

Aloe Vesta Clear Antifungal by is a Otc medication manufactured, distributed, or labeled by Convatec Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Miconazole Nitrate 2 percent

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 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 contact 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.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Bis-Diglyceryl Polyacladipate-2, Mineral Oil, Pertolatum

Package label

NDC: 43553-0003-2

REF 325102

ALOE VESTA ​TM

TREAT

CLEAR ANTIFUNGAL

OINTMENT

• CHG Compatible
• Cures Most:
  
  -Athlete's Foot
  
  -Ringworm
  
  -Jock Itch
  
  -Superficial Yeast Infections
• Fragrance & Dye Free

with 2 percent Miconazole Nitrate and a Natural Botanical

Net Wt. 2 oz. (56g)

Manufactured for:

ConvaTec

ConvaTec Inc.

Skillman, NJ 08558

1-800-422-8811

www.convatec.com

©2015 ConvaTec Inc.

®/ ​TM ​indicates a trademark of ConvaTec Inc.

Store at 15°C - 30°C (59°F - 86°F)

Made in USA

CSX0647D

INGREDIENTS AND APPEARANCE

ALOE VESTA CLEAR ANTIFUNGAL 
miconazole nitrate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43553-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43553-0003-2	56 g in 1 TUBE; Type 0: Not a Combination Product	12/23/2013
2	NDC: 43553-0003-5	141 g in 1 TUBE; Type 0: Not a Combination Product	12/23/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/20/2013

Labeler - Convatec Inc. (080128290)