SANAFITIL ® OINTMENT

Manufacturer: Tarmac Products, Inc
Effective date: 2013-04-30
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:40:57

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11096-190-01	2024-02-16	C162847	48780-1	9d75b9d0-67ed-f424-e053-dadaa90a57ce	SANAFITIL ® OINTMENT
11096-190-01	2020-01-31	C162847	48780-1	9d75b9d0-67ed-f424-e053-dadaa90a57ce	SANAFITIL ® OINTMENT

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
11096-190	11096-190-01

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
BORIC ACID	BORIC ACID	R57ZHV85D4	SHAMPOO / TOPICAL	2 %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
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SYRUP / ORAL		20 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SUSPENSION/ DROPS / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SOLUTION / ORAL		100 mg	Exact identifier — unii candidate 23 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	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	PASTE, DENTIFRICE / DENTAL	1.1 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	POWDER, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
BENZOCAINE	BENZOCAINE	U3RSY48JW5	OINTMENT / TOPICAL	1 %w/w		Exact identifier — unii candidate
MENTHOL	MENTHOL	L7T10EIP3A	GUM, CHEWING / BUCCAL		89 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	GEL / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SUSPENSION / RECTAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	DROPS / NASAL	40.32 mg		Exact identifier — unii candidate 24 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	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	INJECTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET / ORAL	0.7 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION/ DROPS / OPHTHALMIC		48 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	INHALANT / NASAL	32 mg		Exact identifier — unii candidate 24 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	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SUSPENSION / ORAL	15 mg		Exact identifier — unii candidate 23 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SUSPENSION/ DROPS / OPHTHALMIC		22 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	OINTMENT / RECTAL		38 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / SUBLINGUAL		2 mg	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
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	ELIXIR / ORAL		90 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	GEL / OPHTHALMIC	0.5 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	EMULSION / TOPICAL	1.3 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAMUSCULAR		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / PARENTERAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	INJECTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		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
d721a51d-9e59-44dc-a4be-ca6d5d9a537a			43089f7f-486f-4dd0-9a77-e0e0441c1e9e	2024-02-16	Warnings	Exact identifier spl set id: 43089f7f-486f-4dd0-9a77-e0e0441c1e9e

Reported adverse events (FAERS/openFDA)#

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