Label: MICOCILEN ANTIFUNGAL- undecylenic acid liquid
- 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 March 4, 2019
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 29.5 ml Vial Carton
INGREDIENTS AND APPEARANCE
undecylenic acid liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70570-0199 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 Tea Tree Oil (UNII: VIF565UC2G) Isopropyl Alcohol (UNII: ND2M416302) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70570-0199-1 1 in 1 CARTON 03/01/2014 1 29.5 mL in 1 VIAL, GLASS; 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 03/01/2014 Labeler - Arymar Inc. (021650273)