Label: MYCO NAIL A ANTIFUNGAL SOLUTION- undecylenic acid liquid
- NDC Code(s): 52083-242-30
- Packager: Kramer Novis
- 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 November 13, 2019
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- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only. Flammable: Keep away from fire and flame.
When using this product avoid contact with the eyes and mucuos membranes.
Stop use and ask a doctor if irritation occurs or is there is no improvement within 4 weeks.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If you are pregnant or breast-feeding consult a health care professional before using this product.
Clean the affected area and dry thoroughly. Apply a thin layer of Myco Nail A over the affected area twice daily (morning and night) or as directed by a physician. Supervise children in the use of this product. For athlete's foot: pay special attention to spaces between toes; wear well-fitted, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer, consult a physcian.
- Other information
- Inactive ingredients
- Questions or omments:
- PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton
INGREDIENTS AND APPEARANCE
MYCO NAIL A ANTIFUNGAL SOLUTION
undecylenic acid liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-242 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 250 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZYL ACETATE (UNII: 0ECG3V79ZJ) BENZYL ALCOHOL (UNII: LKG8494WBH) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) CHLOROXYLENOL (UNII: 0F32U78V2Q) EUCALYPTOL (UNII: RV6J6604TK) ACETIC ACID (UNII: Q40Q9N063P) ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPIONIC ACID (UNII: JHU490RVYR) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM PROPIONATE HYDRATE (UNII: DK6Y9P42IN) TRIACETIN (UNII: XHX3C3X673) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-242-30 1 in 1 CARTON 01/14/2014 1 30 mL in 1 BOTTLE; 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 01/14/2014 Labeler - Kramer Novis (090158395) Registrant - Kramer Novis (090158395)