SANAFITIL- undecylenic acid ointment

SANAFITIL by

Drug Labeling and Warnings

SANAFITIL by is a Otc medication manufactured, distributed, or labeled by Tarmac Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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: 11096-190
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 g

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11096-190-01	1 in 1 CARTON
1		28.35 g in 1 TUBE

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

Labeler - Tarmac Products, Inc (059890491)

Establishment
Name	Address	ID/FEI	Business Operations
Tarmac Products, Inc		059890491	MANUFACTURE(11096-190)