TINEACIDE

Manufacturer: Blaine Labs Inc.
Effective date: 2023-12-21
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 00:05:22

Label at a glance#

ProductTINEACIDE

Active ingredientTOLNAFTATE

Label structure12 sections

Dosage and administration

Directions Wash the affected ares with soap and water and dry thoroughly. Apply a thin layer over affected area twice daily (morning and night) or as directed by a physician. Supervise children in the use of this product. 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 dail...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Drug facts

Active Ingredient

TOLNAFTATE 1%

Purpose

OTC - PURPOSE SECTION

Purpose

Antifungal

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison control Center right away.

Indications

INDICATIONS & USAGE SECTION

Indications

Cures most athlete's foot (tinea pedis).
Cures most jock itch (tinea cruris) and ring worm (tinea corporis).
Relieves itching, cracking, burning, and scaling which accompany these conditions.
Prevents most athlete's foot (tinea pedis) with daily use.

Warnings

WARNINGS SECTION

Warnings

Do not use
on children under 2 years of age unless directed by a physician
in or near mouth or eyes
for vaginal yeast infections
For external use only

When Using This Product

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes. If eye contact occurs, rinse thoroughly with water.

Stop Use And Consult A Physician

OTC - STOP USE SECTION

Stop use and ask a physician 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).

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

Wash the affected ares with soap and water and dry thoroughly. Apply a thin layer over affected area twice daily (morning and night) or as directed by a physician.
Supervise children in the use of this product.
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.
wash hands after each use.

Other Information

OTHER SAFETY INFORMATION

Other Information

Store at room temperature.

Questions?

OTC - QUESTIONS SECTION

Questions?

Call (800)307-8818, Monday through Friday, 8:00 AM to 5:00 PM (Pacific Time).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Paraffnum Liquidum, Carthamus Tinctorius (Safflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Oreganum Vulgaris (Oregano) Leaf Oil, Tocopheryl acetate, BHT, BHA, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylpapaben.

Package Label Tineacide Solution Physician Formula

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blaine Labs

TINEACIDE SOLUTION PHYSICIAN FORMULA

Antifungal Treatment

Dispensed Only by Physicians

NDC: 63347-511-03

15ml (1/2 oz.)

Proudly Made in the USA

Please Recycle! This package is made from recyclable materials.

Exp. / Lot #

Patent Pending

Blaine Labs

Manufactured by

Blaine Labs, Inc

11037 Lockport Place

Sante Fe Springs, CA 90670

27000-P-BX Rev. 20120921

Blaine Tineacide Sol1

res

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63347-511-03	2022-02-21	C162847	48780-1	d6a99b39-66fc-a426-e053-dadaa90af4c2	273eb424-5dc3-40c8-9ea7-2f732cbd11c9
63347-511-03	2022-01-28	C162847	48780-1	d6a99b39-66fc-a426-e053-dadaa90af4c2	273eb424-5dc3-40c8-9ea7-2f732cbd11c9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63347-511-03	TINEACIDE	15 mL in 1 BOTTLE	LIQUID	15		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63347-511	TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]	9	Current NDC, Legacy NDC, 1 package rows	20231222_273eb424-5dc3-40c8-9ea7-2f732cbd11c9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	4
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	4
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	4
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	4
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	4
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	4
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	4
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	4
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	4
OREGANO LEAF OIL	INACTIVE INGREDIENT	7D0CGR40U1	4
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	4
SAFFLOWER OIL	INACTIVE INGREDIENT	65UEH262IS	4

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

TINEACIDE
TOLNAFTATE
MINERAL OIL
SAFFLOWER OIL
JOJOBA OIL
OREGANO LEAF OIL
.ALPHA.-TOCOPHEROL ACETATE
BUTYLATED HYDROXYTOLUENE
BUTYLATED HYDROXYANISOLE
PHENOXYETHANOL
METHYLPARABEN
ETHYLPARABEN
PROPYLPARABEN
ISOBUTYLPARABEN
BUTYLPARABEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63347-511	63347-511-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TOLNAFTATE	06KB629TKV	ACTIB
MINERAL OIL	T5L8T28FGP	IACT
SAFFLOWER OIL	65UEH262IS	IACT
JOJOBA OIL	724GKU717M	IACT
OREGANO LEAF OIL	7D0CGR40U1	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
BUTYLATED HYDROXYANISOLE	REK4960K2U	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
ETHYLPARABEN	14255EXE39	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
ISOBUTYLPARABEN	0QQJ25X58G	IACT
BUTYLPARABEN	3QPI1U3FV8	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 2 · 114 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
SAFFLOWER OIL	SAFFLOWER OIL	65UEH262IS	LOTION / TOPICAL		3510 mg	Exact identifier — unii+route 2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / TOPICAL		9938 mg	Exact identifier — unii+route 20 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii+route 20 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii+route 30 equally ranked IID candidates
SAFFLOWER OIL	SAFFLOWER OIL	65UEH262IS	LOTION / TOPICAL		3510 mg	Exact identifier — unii+route 2 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL, METERED / TOPICAL		4 mg	Exact identifier — unii+route 24 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii+route 20 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	LOTION / TOPICAL		1000 mg	Exact identifier — unii+route 24 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii+dosage form 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	GRANULE, FOR SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii+route 30 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / TOPICAL		3 mg	Exact identifier — unii+route 24 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii+route 20 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii+route 24 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	Exact identifier — unii+route 24 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii+route 12 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL / TOPICAL		8 mg	Exact identifier — unii+route 24 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	GEL / TOPICAL		7 mg	Exact identifier — unii+route 8 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	LOTION / TOPICAL		1000 mg	Exact identifier — unii+route 24 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM, AUGMENTED / TOPICAL	0.2 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY / TOPICAL		3 mg	Exact identifier — unii+route 24 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	GRANULE, FOR SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM, AUGMENTED / TOPICAL	0.2 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii+route 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii+route 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii+route 30 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii+route 24 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii+route 30 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii+route 12 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	CREAM / TOPICAL		2 mg	Exact identifier — unii+route 8 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii+route 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii+route 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii+route 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / TOPICAL		3 mg	Exact identifier — unii+route 24 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii+route 20 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	LOTION / TOPICAL	NA		Exact identifier — unii+route 8 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii+route 30 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SWAB / TOPICAL	0.5 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii+route 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii+route 30 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
TINEACIDE	TOLNAFTATE	Blaine Labs Inc.	273eb424-5dc3-40c8-9ea7-2f732cbd11c9	2023-12-21	Warnings	Exact identifier ndc (package): 63347-511-03 ndc (product): 63347-511 ndc11 (package): 63347051103 spl id: 7929e269-caee-4126-a9ba-14cbc2dd73d1 spl set id: 273eb424-5dc3-40c8-9ea7-2f732cbd11c9

Reported adverse events (FAERS/openFDA)#

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