NDC | 43689-0025-1, 43689-0025-2 |
Set ID | e206738e-6b24-4b03-a84f-7c2521d022ea |
Category | HUMAN OTC DRUG LABEL |
Packager | The Magni Group Inc |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- Drug Facts
- Active ingredients (in cream)
- Uses
- Warnings
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Directions
• Wash the affected area and dry thoroughly • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor • Supervise children in the use of this product • For athlete’s foot: Pay special 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 doctor • This product is not effective on the scalp or nails
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Inactive ingredients
Allium Sativum Garlic (Plant) Extract, C12-15 Alkyl Benzoate, Ceteth-20, Cetyl Alcohol, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Garcinia Indica Seed Butter, Hydroxyacetophenone, Isopropyl Palmitate, Isopropyl Myristate, Lemon Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sodium Acrylate/Sodium Acryldimethyl Taurate Copolymer, Tocopheryl Acetate, Water
- Package Labeling:
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INGREDIENTS AND APPEARANCE
DB ANTIFUNGAL FOOT
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43689-0025 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 ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETETH-20 (UNII: I835H2IHHX) CETYL ALCOHOL (UNII: 936JST6JCN) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EUCALYPTUS OIL (UNII: 2R04ONI662) GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LEMON OIL (UNII: I9GRO824LL) TEA TREE OIL (UNII: VIF565UC2G) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALMOND OIL (UNII: 66YXD4DKO9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43689-0025-1 113 g in 1 JAR; Type 0: Not a Combination Product 04/27/2017 2 NDC:43689-0025-2 1 in 1 BOX 04/27/2017 2 113 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/27/2017 Labeler - The Magni Group Inc (113501902)