Label: ALOE VESTA CLEAR ANTIFUNGAL- miconazole nitrate ointment
- NDC Code(s): 43553-0003-2, 43553-0003-5
- Packager: Convatec Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated December 21, 2017
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
Miconazole Nitrate 2 percentClose
- 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.
For external use only.
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.
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, PertolatumClose
- Package label
ALOE VESTA TM
- CHG Compatible
- Cures Most:
-Superficial Yeast Infections
- Fragrance & Dye Free
with 2 percent Miconazole Nitrate and a Natural Botanical
Net Wt. 2 oz. (56g)
Skillman, NJ 08558
©2015 ConvaTec Inc.
®/ TM indicates a trademark of ConvaTec Inc.
Store at 15°C - 30°C (59°F - 86°F)
Made in USA
- 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)