Sanafitil (Undecylenic Acid) Liquid [Zurich Medical Labs, Llc] -

SANAFITIL (UNDECYLENIC ACID) LIQUID [ZURICH MEDICAL LABS, LLC]
PDF | XML

NDC	61357-146-01
Set ID	9c105c97-038a-4c3a-8a32-9d10a10c8c00
Category	HUMAN OTC DRUG LABEL
Packager	ZURICH MEDICAL LABS, LLC
Generic Name
Product Class
Product Number
Application Number	PART333C

View All Sections

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Undecylenic Acid (UNII: K3D86KJ24N) (Undecylenic Acid - UNII:K3D86KJ24N)	Undecylenic Acid	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:61357-146-01	1 in 1 CARTON
1		30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333C	08/24/1966

Labeler - ZURICH MEDICAL LABS, LLC (071904097)

Name	Address	ID/FEI	Business Operations
Establishment
ZURICH MEDICAL LABS, LLC		071904097	MANUFACTURE(61357-146)

View All Sections