Tineacide

Manufacturer: Blaine Labs Inc.
Effective date: 2011-01-21
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:27:01

Label at a glance#

ProductTineacide Physician Formula

Active ingredientUNDECYLENIC ACID

Label structure8 sections

Indications and uses

Cures Athlete's Foot (tinea pedis) jock itch (tinea cruris) and ringworm (tinea corporis).

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera, Cetyl Alcohol, Clotrimazole, Coco-Caprylate Caprate, Disodium EDTA, Glyceryl Stearate, Hydroxyethylcellulose, Lavender Oil, Methylparaben, PEG-100, Stearate, Polysorbate 60, Propylparaben, Stearic Acid, Tea Tree Oil, Triethanolamine, Urea, Water

Uses

OTC - PURPOSE SECTION

Cures Athlete's Foot (tinea pedis) jock itch (tinea cruris) and ringworm (tinea corporis).

Uses

INDICATIONS & USAGE SECTION

For effective relief of itching, cracking, burning and discomfort which can accompany these conditions.

Ask Your Physician

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not use on children under 2 years of age unless directed by a physician

When Using This Product

DOSAGE & ADMINISTRATION SECTION

Wash the affected area with soap and water and dry thoroughly. Apply sparingly over affected area twice daily (morning and night) or as directed by a physician. For athlete's foot pay special attention to spaces between the toes. wear well-fitting ventilated shoes and change shoes and socks at least once daily. For athlete's foot and ringworm use daily for 4 weeks. for jock itch use daily for 2 weeks. If condition persists longer, consult a physician.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes. If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch) discontinue use and consult a physician. Keep this and all drugs out of the reach of children. In case of accidental ingestion seek professional assistance or contact a poison control center immediately.

Tineacide Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tineacide Antifungal Cream Physician Formula
Dispensed by a physician only.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1250976	Tineacide Antifungal 10 % Topical Cream	PSN	1
1250980	Tineacide Antifungal 13 % Topical Cream	PSN	1
830155	undecylenic acid 10 % Topical Cream	PSN	1
1250978	undecylenic acid 13 % Topical Cream	PSN	1
1250976	undecylenic acid 100 MG/ML Topical Cream [Tineacide Antifungal]	SBD	1
1250980	undecylenic acid 130 MG/ML Topical Cream [Tineacide Antifungal]	SBD	1
830155	undecylenic acid 100 MG/ML Topical Cream	SCD	1
1250978	undecylenic acid 130 MG/ML Topical Cream	SCD	1
1250976	Tineacide Antifungal 10 % Topical Cream	SY	1
1250976	Tineacide Antifungal 100 MG/ML Topical Cream	SY	1
1250980	Tineacide Antifungal 13 % Topical Cream	SY	1
1250980	Tineacide Antifungal 130 MG/ML Topical Cream	SY	1
830155	undecylenic acid 10 % Topical Cream	SY	1
1250978	undecylenic acid 13 % Topical Cream	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b64d2752-34ef-378a-1f4f-8bff32b0d1ae	Product name	4	20250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9	Product name	2	20250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65373-100-01	2020-01-31	C162847	48780-1	9d75b9d0-5d34-f424-e053-dadaa90a57ce	3a7caf9f-2552-41be-a7d4-ac3a18b5a0d5
65373-500-01	2020-01-31	C162847	48780-1	9d75b9d0-5d34-f424-e053-dadaa90a57ce	3a7caf9f-2552-41be-a7d4-ac3a18b5a0d5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65373-100-01	Tineacide Physician Formula	35.4 g in 1 BOTTLE	CREAM	35.4		1
65373-500-01	Tineacide	35.4 g in 1 BOTTLE	CREAM	35.4		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65373-100	TINEACIDE PHYSICIAN FORMULA (UNDECYLENIC ACID) CREAM TINEACIDE (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1	Legacy NDC, 1 package rows	20110125_3a7caf9f-2552-41be-a7d4-ac3a18b5a0d5.zip
65373-500	TINEACIDE PHYSICIAN FORMULA (UNDECYLENIC ACID) CREAM TINEACIDE (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1	Legacy NDC, 1 package rows	20110125_3a7caf9f-2552-41be-a7d4-ac3a18b5a0d5.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
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	1
CLOTRIMAZOLE	INACTIVE INGREDIENT	G07GZ97H65	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
ENGLISH LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	INACTIVE INGREDIENT	8136Y38GY5	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
POLYOXYL 100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	1
UREA	INACTIVE INGREDIENT	8W8T17847W	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

Tineacide Physician Formula
UNDECYLENIC ACID
WATER
CETYL ALCOHOL
ALOE VERA LEAF
CLOTRIMAZOLE
EDETATE DISODIUM
GLYCERYL MONOSTEARATE
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)
ENGLISH LAVENDER OIL
METHYLPARABEN
POLYOXYL 100 STEARATE
POLYSORBATE 60
PROPYLPARABEN
STEARIC ACID
TEA TREE OIL
TROLAMINE
UREA
Tineacide

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65373-100	65373-100-01
65373-500	65373-500-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
UNDECYLENIC ACID	K3D86KJ24N	ACTIB
WATER	059QF0KO0R	IACT
CETYL ALCOHOL	936JST6JCN	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
CLOTRIMAZOLE	G07GZ97H65	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	8136Y38GY5	IACT
ENGLISH LAVENDER OIL	ZBP1YXW0H8	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYOXYL 100 STEARATE	YD01N1999R	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TEA TREE OIL	VIF565UC2G	IACT
TROLAMINE	9O3K93S3TK	IACT
UREA	8W8T17847W	IACT
UNDECYLENIC ACID	K3D86KJ24N	ACTIB
WATER	059QF0KO0R	IACT
CETYL ALCOHOL	936JST6JCN	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
CLOTRIMAZOLE	G07GZ97H65	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	8136Y38GY5	IACT
ENGLISH LAVENDER OIL	ZBP1YXW0H8	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYOXYL 100 STEARATE	YD01N1999R	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TEA TREE OIL	VIF565UC2G	IACT
TROLAMINE	9O3K93S3TK	IACT
UREA	8W8T17847W	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 6 · 347 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	EMULSION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SPRAY / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION, CONCENTRATE / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, METERED / RECTAL	ADJ PH		Exact identifier — unii candidate 22 equally ranked IID candidates
UREA	UREA	8W8T17847W	CREAM / VAGINAL	0.64 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	TABLET / ORAL		2 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRA-ARTICULAR	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
UREA	UREA	8W8T17847W	INSERT / VAGINAL		50 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 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
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRA-ARTICULAR	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	AEROSOL, FOAM / TOPICAL		30 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
POLYOXYL 100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, ORALLY DISINTEGRATING / ORAL		9 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUPPOSITORY / RECTAL	0.05 mg/mg		Exact identifier — unii candidate 13 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYOXYL 100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	GRANULE, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, DELAYED RELEASE / ORAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / TOPICAL		24 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / VAGINAL	0.1 %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
e96c0c50-9c4d-4dc3-9eb8-481cabfc42fa			3a7caf9f-2552-41be-a7d4-ac3a18b5a0d5	2011-01-21	Warnings	Exact identifier spl id: e96c0c50-9c4d-4dc3-9eb8-481cabfc42fa spl set id: 3a7caf9f-2552-41be-a7d4-ac3a18b5a0d5

Reported adverse events (FAERS/openFDA)#

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