SANAFITIL- undecylenic acid liquid

Sanafitil by

Drug Labeling and Warnings

Sanafitil 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 Ingredients

Undecylenic Acid 10%

Purpose

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

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)

INGREDIENTS AND APPEARANCE

SANAFITIL 
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61357-146
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 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61357-146-01	1 in 1 CARTON
1		30 mL 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(61357-146)