Bio-Scriptives Extreme AF

Manufacturer: BioChemics, Inc. | Coastal Products Company
Effective date: 2011-07-27
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 22:28:58

Label at a glance#

ProductBio-Scriptives Extreme AF

Active ingredientTOLNAFTATE

Label structure10 sections

Indications and uses

■ Proven clinically effective in the treatment of athlete's foot. ■ Relieves itching and burning feet.

Dosage and administration

■ Wash the feet and dry thoroughly. ■ Apply a thin layer of product to the feet once or twice daily (morning and/or night). ■ Supervise children in the use of this product. ■ Pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily. ■ Do not use if safety seal is broken.

Contacts and useful links#

PhoneLabel contact978-750-0790

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

■ Proven clinically effective in the treatment of athlete's foot.
■ Relieves itching and burning feet.

Warnings

WARNINGS SECTION

■ Do not use on children under 2 years of age.
■ Do not use for diaper rash.
■ For external use only.
■ Avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation occurs or if there is no improvement within 4 weeks.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Wash the feet and dry thoroughly.
■ Apply a thin layer of product to the feet once or twice daily (morning and/or night).
■ Supervise children in the use of this product.
■ Pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
■ Do not use if safety seal is broken.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Glyceryl Stearate SE, Stearyl Alcohol, Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Olive Oil, Menthol, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, L-Arginine hydroxide, PEG-40 Hdrogenated Castor Oil, Eucalyptus Globulus, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Althaea Officinalis Extract, Echinacea Angustifolia Extract, Allantoin, Tagetes Erecta Extract, Sodium Chloride, Ascophyllum Nodosum Extract, Xanthan Gum, Azadirachta Indica (Neem) Seed Oil, Methylisothiazolinone

Reference

REFERENCES SECTION

Distributed by BioChemics dba Bio-Scriptives

99 Rosewood Dr. #260 - Danvers, MA 01923

978-750-0790

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Enter section text here

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
103951	tolnaftate 1 % Topical Cream	PSN	6
103951	tolnaftate 10 MG/ML Topical Cream	SCD	6
103951	tolnaftate 1 % Topical Cream	SY	6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60608-013-00	2019-10-29	C162847	48780-1	960f7f55-d5d7-8e05-e053-dbdaa90a074a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60608-013-00	Bio-Scriptives Extreme AF	56.69 g in 1 BOTTLE, PUMP	CREAM	56.69		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60608-013	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6	Legacy NDC, 1 package rows	20110727_e901c834-dcac-4d12-85f2-655ca9239cfe.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	6
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	6
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	6
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	6
ALTHAEA OFFICINALIS ROOT	INACTIVE INGREDIENT	TRW2FUF47H	6
ARGININE HYDROCHLORIDE	INACTIVE INGREDIENT	F7LTH1E20Y	6
ASCOPHYLLUM NODOSUM	INACTIVE INGREDIENT	168S4EO8YJ	6
AZADIRACHTA INDICA SEED OIL	INACTIVE INGREDIENT	4DKJ9B3K2T	6
CARBOMER COPOLYMER TYPE A	INACTIVE INGREDIENT	71DD5V995L	6
ECHINACEA ANGUSTIFOLIA LEAF	INACTIVE INGREDIENT	FS7G8S6PJ8	6
EUCALYPTUS GLOBULUS LEAF	INACTIVE INGREDIENT	S546YLW6E6	6
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	6
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	6
MELALEUCA ALTERNIFOLIA LEAF	INACTIVE INGREDIENT	G43C57162K	6
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	6
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	6
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	6
POLYOXYL 40 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	7YC686GQ8F	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	6
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	6
TAGETES ERECTA FLOWER	INACTIVE INGREDIENT	UH5X33P33E	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	6
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	6

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

Bio-Scriptives Extreme AF
Tolnaftate
CARBOMER COPOLYMER TYPE A
PROPYLENE GLYCOL
XANTHAN GUM
WATER
ARGININE HYDROCHLORIDE
SODIUM CHLORIDE
ALOE VERA LEAF
ALLANTOIN
ALTHAEA OFFICINALIS ROOT
ECHINACEA ANGUSTIFOLIA LEAF
ASCOPHYLLUM NODOSUM
TAGETES ERECTA FLOWER
STEARYL ALCOHOL
METHYLISOTHIAZOLINONE
MENTHOL
EUCALYPTUS GLOBULUS LEAF
GLYCERYL MONOSTEARATE
OLIVE OIL
POLYOXYL 40 HYDROGENATED CASTOR OIL
AZADIRACHTA INDICA SEED OIL
ISOPROPYL ALCOHOL
MELALEUCA ALTERNIFOLIA LEAF

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60608-013	60608-013-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TOLNAFTATE	06KB629TKV	ACTIB
CARBOMER COPOLYMER TYPE A	71DD5V995L	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
XANTHAN GUM	TTV12P4NEE	IACT
WATER	059QF0KO0R	IACT
ARGININE HYDROCHLORIDE	F7LTH1E20Y	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
ALLANTOIN	344S277G0Z	IACT
ALTHAEA OFFICINALIS ROOT	TRW2FUF47H	IACT
ECHINACEA ANGUSTIFOLIA LEAF	FS7G8S6PJ8	IACT
ASCOPHYLLUM NODOSUM	168S4EO8YJ	IACT
TAGETES ERECTA FLOWER	UH5X33P33E	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
METHYLISOTHIAZOLINONE	229D0E1QFA	IACT
MENTHOL	L7T10EIP3A	IACT
EUCALYPTUS GLOBULUS LEAF	S546YLW6E6	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
OLIVE OIL	6UYK2W1W1E	IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	IACT
AZADIRACHTA INDICA SEED OIL	4DKJ9B3K2T	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
MELALEUCA ALTERNIFOLIA LEAF	G43C57162K	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 · 327 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MENTHOL	MENTHOL	L7T10EIP3A	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET / ORAL		231 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OIL	POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	TABLET, EXTENDED RELEASE / ORAL		50 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / OPHTHALMIC		10 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / AURICULAR (OTIC)		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVENOUS		28773 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A	CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	71DD5V995L	EMULSION / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 2 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRABURSAL	9 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	SUPPOSITORY / VAGINAL	8.5 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVASCULAR	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / RECTAL		452 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	ELIXIR / ORAL	1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	LOTION / TOPICAL		32468 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING / ORAL	0.15 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL	1.35 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		360 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAPERITONEAL	0.54 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOLUTION / ORAL	425 mg/1ml		Exact identifier — unii candidate 5 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	IMPLANT / SUBCUTANEOUS	77 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERINEURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ORAL		98 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / DENTAL	0.4 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / SUBLINGUAL		2 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OIL	POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	CAPSULE, COATED / ORAL	101.25 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / TOPICAL	0.23 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVENOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 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
21203d45-e7b4-4bb2-a475-f8711a6ba65d			e901c834-dcac-4d12-85f2-655ca9239cfe	2011-07-27	Warnings	Exact identifier spl id: 21203d45-e7b4-4bb2-a475-f8711a6ba65d spl set id: e901c834-dcac-4d12-85f2-655ca9239cfe

Reported adverse events (FAERS/openFDA)#

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