ALOE VESTA ANTIFUNGAL- miconazole nitrate ointment

ALOE VESTA ANTIFUNGAL by

Drug Labeling and Warnings

ALOE VESTA ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by ConvaTec, Inc., Guest Packaging LLC, Medicia. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

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