Label: FUNGOID TINCTURE- miconazole nitrate tincture
- NDC Code(s): 0884-0293-01
- Packager: Pedinol Pharmacal, 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 May 18, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only
When using this product
- avoid contact with the eyes.
- if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
- clean 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 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
- if condition persists longer, consult a doctor
- this product is not effective on scalp or nails.
- Other information
- Inactive ingredients
- Questions or comments?
- Fungoid Tincture – 1 fl. oz. (29.57 mL) Carton
INGREDIENTS AND APPEARANCE
miconazole nitrate tincture
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0884-0293 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 mL Inactive Ingredients Ingredient Name Strength Acetic Acid (UNII: Q40Q9N063P) Benzyl Alcohol (UNII: LKG8494WBH) Isopropyl Alcohol (UNII: ND2M416302) Laureth-4 (UNII: 6HQ855798J) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0884-0293-01 1 in 1 CARTON 04/11/2012 1 29.57 mL in 1 BOTTLE, WITH APPLICATOR; 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 04/11/2012 Labeler - Pedinol Pharmacal, Inc. (064737125) Establishment Name Address ID/FEI Business Operations EMS Acquisition Corp. 048602791 MANUFACTURE(0884-0293)