SANAFITIL TALCO- undecylenic acid and zinc undecylenate powder

Sanafitil Talco by

Drug Labeling and Warnings

Sanafitil Talco by is a Otc medication manufactured, distributed, or labeled by ZURICH MEDICAL LABS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Undecylenic Acid 2%	Antifungal
Zinc Undecylenate 20%	Antifungal

Uses

• Cures most athlete's foot, jock itch & ringworm
• Relieves itching, burning, cracking, and discomfort which accompany these conditions

Warning

• For external use only.
• 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

• 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

Store at 59° - 86° F

Other ingredients

talc

PRINCIPAL DISPLAY PANEL - 57 g Bottle Label

SANAFITIL®

ANTIFUNGAL
POWDER

• Treats most Athlete's foot, Jock itch & Ringworm

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

INGREDIENTS AND APPEARANCE

SANAFITIL TALCO 
undecylenic acid and zinc undecylenate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61357-152
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	20 mg  in 1 g
ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	ZINC UNDECYLENATE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61357-152-01	1 in 1 CARTON
1		57 g 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(61357-152)