Label: ALOE VESTA CLEAR ANTIFUNGAL 56G- miconazole nitrate ointment
- NDC Code(s): 11099-0003-2
- Packager: Guest Packaging LLC.
- 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 June 18, 2016
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- Drug Facts
- 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.
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
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.
- Active ingredient
- Inactive ingredients
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
ALOE VESTA CLEAR ANTIFUNGAL 56G
miconazole nitrate ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11099-0003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 1.12 g in 56 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11099-0003-2 56 g in 1 TUBE; Type 0: Not a Combination Product 06/09/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 06/09/2016 Labeler - Guest Packaging LLC. (001773076) Establishment Name Address ID/FEI Business Operations Guest Packaging LLC. 001773076 manufacture(11099-0003)