Sanafitil

Manufacturer: ZURICH MEDICAL LABS, LLC
Effective date: 2014-03-21
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:39:05

Label at a glance#

ProductSanafitil

Active ingredientUndecylenic Acid

Label structure9 sections

Indications and uses

For the treatment of most athlete's foot, jock itch & ringworm Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

Dosage and administration

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...

Storage and handling

Store at 59° - 86° F (15°- 30°C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 10%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

For the treatment of most athlete's foot, jock itch & ringworm
Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

Warning

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes and mucous membrane.

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age except under the advice and supervision of a doctor.
Not for diaper rash

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion seek professional assistance or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Store at 59° - 86° F (15°- 30°C)

Other ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SANAFITIL^®
(Undecylenic Acid 10%)

ANTIFUNGAL

OINTMENT

1 OZ. (28.35g)

Principal Display Panel - 28.35 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1534858	SANAFITIL Antifungal 10 % Topical Ointment	PSN	1
1250560	undecylenic acid 10 % Topical Ointment	PSN	1
1534858	undecylenic acid 0.1 MG/MG Topical Ointment [Sanafitil Antifungal]	SBD	1
1250560	undecylenic acid 0.1 MG/MG Topical Ointment	SCD	1
1534858	Sanafitil Antifungal 0.1 MG/MG Topical Ointment	SY	1
1534858	Sanafitil Antifungal 10 % Topical Ointment	SY	1
1250560	undecylenic acid 10 % Topical Ointment	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61357-149-01	2019-11-27	C162847	48780-1	9855e2a2-371a-60a7-e053-dbdaa90a05bd	Sanafitil ® Ungüento

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61357-149-01	Sanafitil	28.35 g in 1 TUBE	OINTMENT	28.35		1
61357-149-01	Sanafitil	1 in 1 CARTON	OINTMENT	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61357-149	SANAFITIL (UNDECYLENIC ACID) OINTMENT [ZURICH MEDICAL LABS, LLC]	1	Legacy NDC, 2 package rows	20140424_62ef352c-0cc4-400a-94e2-24777638589a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Undecylenic Acid	ACTIVE INGREDIENT	K3D86KJ24N	1
Undecylenic Acid	ACTIVE MOIETY	K3D86KJ24N	1
BENZOCAINE	INACTIVE INGREDIENT	U3RSY48JW5	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	1
HEXYL SALICYLATE	INACTIVE INGREDIENT	8F78EY72YL	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Sanafitil
Undecylenic Acid
PETROLATUM
BENZOCAINE
PARAFFIN
HEXYL SALICYLATE
BENZOIC ACID
BORIC ACID
METHYL SALICYLATE
METHYLPARABEN
PROPYLPARABEN
MENTHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61357-149	61357-149-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Undecylenic Acid	K3D86KJ24N	ACTIB
PETROLATUM	4T6H12BN9U	IACT
BENZOCAINE	U3RSY48JW5	IACT
PARAFFIN	I9O0E3H2ZE	IACT
HEXYL SALICYLATE	8F78EY72YL	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
BORIC ACID	R57ZHV85D4	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
MENTHOL	L7T10EIP3A	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 249 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	AEROSOL, FOAM / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	GEL / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RESPIRATORY (INHALATION)	0.03 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SYRUP / ORAL	7.5 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	LOZENGE / ORAL		53 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 23 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL		300 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	JELLY / VAGINAL	1 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	PASTE, DENTIFRICE / DENTAL	4.7 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CREAM / VAGINAL		10 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	15 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	OINTMENT / TOPICAL		2860 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, EXTENDED RELEASE / ORAL		321 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CAPSULE / ORAL	0.87 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	MOUTHWASH / BUCCAL	0.15 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	AEROSOL, FOAM / TOPICAL		14235 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e56542a5-1348-43e0-b28f-8056e4b8cdd1			62ef352c-0cc4-400a-94e2-24777638589a	2014-03-21	Warnings	Exact identifier spl id: e56542a5-1348-43e0-b28f-8056e4b8cdd1 spl set id: 62ef352c-0cc4-400a-94e2-24777638589a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.