Label: SANAFITIL- undecylenic acid ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 61357-149-01 - 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 21, 2014
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
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Warning
- For external use only.
- Do not use on children under 2 years of age except under the advice and supervision of a doctor.
- Not for diaper rash
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Directions
- Clean affected area and dry thoroughly.
- Apply a thin layer over affected area twice daily (morning and 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 - 28.35 g Tube Carton
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INGREDIENTS AND APPEARANCE
SANAFITIL
undecylenic acid ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61357-149 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 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) BENZOCAINE (UNII: U3RSY48JW5) PARAFFIN (UNII: I9O0E3H2ZE) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61357-149-01 1 in 1 CARTON 1 28.35 g in 1 TUBE 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(61357-149)