SANAFITIL- undecylenic acid ointment 
ZURICH MEDICAL LABS, LLC

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.

----------

Sanafitil® Ungüento

Drug Facts

Active Ingredients

Undecylenic Acid 10%

Purpose

Antifungal

Uses

Warning

  • When using this product avoid contact with eyes and mucous membrane.

  • Do not use on children under 2 years of age except under the advice and supervision of a doctor.
  • Not for diaper rash

Stop use and ask a doctor if:

  • Irritation occurs
  • There is no improvement within 4 weeks of treatment for athlete's foot and ringworm and 2 weeks of treatment for jock itch discontinue use and consult a doctor.

KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion seek professional assistance or contact a poison control center right away.

Directions

Other Information

Store at 59° - 86° F (15°- 30°C)

Other ingredients

petrolatum white, benzocaine, paraffin wax, salicylic acid, benzoic acid, boric acid, methyl salicylate, methyl paraben, propyl paraben, menthol crystals

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton

SANAFITIL®
(Undecylenic Acid 10%)

ANTIFUNGAL

OINTMENT

1 OZ. (28.35g)

Principal Display Panel - 28.35 g Tube Carton
SANAFITIL 
undecylenic acid ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61357-149
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Undecylenic Acid (UNII: K3D86KJ24N) (Undecylenic Acid - UNII:K3D86KJ24N) Undecylenic Acid100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61357-149-011 in 1 CARTON
128.35 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C08/24/1966
Labeler - ZURICH MEDICAL LABS, LLC (071904097)
Establishment
NameAddressID/FEIBusiness Operations
ZURICH MEDICAL LABS, LLC071904097MANUFACTURE(61357-149)

Revised: 3/2014
Document Id: e56542a5-1348-43e0-b28f-8056e4b8cdd1
Set id: 62ef352c-0cc4-400a-94e2-24777638589a
Version: 1
Effective Time: 20140321
 
ZURICH MEDICAL LABS, LLC