SANAFITIL TALCO- undecylenic acid and zinc undecylenate powder 
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® Talco

Drug Facts

Active IngredientsPurpose
Undecylenic Acid 2%Antifungal
Zinc Undecylenate 20%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.

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

talc

PRINCIPAL DISPLAY PANEL - 57 g Bottle Label

SANAFITIL®

ANTIFUNGAL
POWDER

NET WEIGHT / PESO
NETO : 2 OZ (57 g)

Principal Display Panel - 57 g Bottle Label
SANAFITIL TALCO 
undecylenic acid and zinc undecylenate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61357-152
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID20 mg  in 1 g
ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N) ZINC UNDECYLENATE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61357-152-011 in 1 CARTON
157 g 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(61357-152)

Revised: 3/2014
Document Id: 4b57c6de-c555-41a0-8789-4cc84a62f16b
Set id: 105c961c-81ee-4b44-b39e-1501132114f0
Version: 1
Effective Time: 20140312
 
ZURICH MEDICAL LABS, LLC