Label: SANAFITIL- undecylenic acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 61357-146-01 - Packager: ZURICH MEDICAL LABS, LLC
- 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.
Drug Label Information
Updated March 20, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warning
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Directions
- Clean affected area and dry thoroughly.
- Apply a thin layer over affected area twice daily (morning & night) or as directed by a doctor.
- For athlete's foot pay special attention to the space between the toes. Wear well fitting, ventilated shoes and change shoes & socks at least once a day.
- For athlete's foot and ringworm, use daily for 4 weeks
- For jock itch use daily for 2 weeks.
- Supervise Children in use of this product.
- Product not effective in the scalp or nails.
- Other Information
- Other ingredients
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
SANAFITIL
undecylenic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61357-146 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 BENZOCAINE (UNII: U3RSY48JW5) HEXYL SALICYLATE (UNII: 8F78EY72YL) BENZOIC ACID (UNII: 8SKN0B0MIM) BORIC ACID (UNII: R57ZHV85D4) METHYL SALICYLATE (UNII: LAV5U5022Y) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) MENTHOL (UNII: L7T10EIP3A) ISOPROPYL ALCOHOL (UNII: ND2M416302) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61357-146-01 1 in 1 CARTON 1 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333C 08/24/1966 Labeler - ZURICH MEDICAL LABS, LLC (071904097) Establishment Name Address ID/FEI Business Operations ZURICH MEDICAL LABS, LLC 071904097 MANUFACTURE(61357-146)