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

SANAFITIL (UNDECYLENIC ACID) OINTMENT [ZURICH MEDICAL LABS, LLC]
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NDC	61357-149-01
Set ID	62ef352c-0cc4-400a-94e2-24777638589a
Category	HUMAN OTC DRUG LABEL
Packager	ZURICH MEDICAL LABS, LLC
Generic Name
Product Class
Product Number
Application Number	PART333C

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SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredients

Undecylenic Acid 10%
Purpose

Antifungal
Uses
- For the treatment of most athlete's foot, jock itch & ringworm
- Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.
Warning
- For external use only.
- 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.
- Not for diaper rash
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 and 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 (15°- 30°C)
Other ingredients

petrolatum white, benzocaine, paraffin wax, salicylic acid, benzoic acid, boric acid, methyl salicylate, methyl paraben, propyl paraben, menthol crystals
PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton

SANAFITIL®
(Undecylenic Acid 10%)

ANTIFUNGAL

OINTMENT

1 OZ. (28.35g)

INGREDIENTS AND APPEARANCE

SANAFITIL
undecylenic acid ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61357-149
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 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
BENZOCAINE (UNII: U3RSY48JW5)
PARAFFIN (UNII: I9O0E3H2ZE)
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)

#	Item Code	Package Description
Packaging
1	NDC:61357-149-01	1 in 1 CARTON
1		28.35 g in 1 TUBE

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(61357-149)

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