NDC | 62654-147-01 |
Set ID | 69c5340d-9abd-43bf-a90b-9568d615f06f |
Category | HUMAN OTC DRUG LABEL |
Packager | Central Solutions Inc |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
Cleanse the affected area and dry thoroughly.
Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician. Supervise children in the use of this product.
Athlete's foot
Pay special attention to the spaces between toes
wear well-fitting, ventilated shoes and change shoes and socks at least once daily
Athlete's foot and ringworm
use daily for 4 weeks
Jock Itch
use daily for 2 weeks. If condition persists longer, consult a doctor.
This product is not effective on scalp or nails.
- STORAGE AND HANDLING
-
INACTIVE INGREDIENT
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Cyclopentasiloxane, DMDM Hydantoin, Iodopropynyl Butylcarbamate, Glycerin, Glyceryl Stearate, PEG 100 Stearate, Isopropyl Palmitate, Polyquaternium-37, Propylene Glycol Dicaprylate Dicaprate, PPG-1 Trideceth-6, Propylene Glycol, Purified Water, Triethanolamine
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BOA VIDA ANTIFUNGAL
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62654-147 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) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DMDM HYDANTOIN (UNII: BYR0546TOW) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN) PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2) PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA) PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62654-147-01 113 g in 1 TUBE; Type 0: Not a Combination Product 09/10/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 09/10/2018 Labeler - Central Solutions Inc (007118524) Establishment Name Address ID/FEI Business Operations Central Solutions Inc 007118524 manufacture(62654-147)