SANAFITIL- undecylenic acid liquid 
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.

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Sanafitil® Solución

Drug Facts

Active Ingredients

Undecylenic Acid 10%

Purpose

Antifungal

Uses

Warning

  • Not for diaper rash

  • 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.

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

Other ingredients

isopropyl alcohol, purified water, benzocaine, salicylic acid, benzoic acid, methyl salicylate, boric acid, methyl paraben, mentol, propyl paraben, FD&C red #22.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

SANAFITIL®

ANTIFUNGAL
SOLUTION

• Relieves itching, burning, cracking, and
discomfort

1 OZ (30mL)

Principal Display Panel - 30 mL Bottle Carton
SANAFITIL 
undecylenic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61357-146
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Undecylenic Acid (UNII: K3D86KJ24N) (Undecylenic Acid - UNII:K3D86KJ24N) Undecylenic Acid100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61357-146-011 in 1 CARTON
130 mL in 1 BOTTLE
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(61357-146)

Revised: 3/2014
Document Id: 39fa6269-46d0-476f-8516-310465dcc67e
Set id: 9c105c97-038a-4c3a-8a32-9d10a10c8c00
Version: 1
Effective Time: 20140320
 
ZURICH MEDICAL LABS, LLC