Label: EMONINAIL ANTIFUNGAL- undecylenic acid liquid
- NDC Code(s): 65121-071-08
- Packager: Pure Source, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 5, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- 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 andsocks 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 the scalp or nails.
- Other Information
- Inactive Ingredients
- Other information
- Package Labeling:
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INGREDIENTS AND APPEARANCE
EMONINAIL ANTIFUNGAL
undecylenic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65121-071 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SUNFLOWER OIL (UNII: 3W1JG795YI) CETYL ALCOHOL (UNII: 936JST6JCN) POLYSORBATE 20 (UNII: 7T1F30V5YH) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) GLYCERIN (UNII: PDC6A3C0OX) TEA TREE OIL (UNII: VIF565UC2G) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65121-071-08 24 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 05/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 05/01/2020 Labeler - Pure Source, LLC (080354456) Establishment Name Address ID/FEI Business Operations Pure Source, LLC 080354456 manufacture(65121-071)