SPAI-SONS

Manufacturer: SPAI-SONS PHARAMCUETICAL INTERNATIONAL COSMETICS | SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS
Effective date: 2012-06-06
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:32:26

Label at a glance#

ProductSPAI-SONS ACID ANTI-DANDRUFF

Active ingredientSULFUR

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

This formula includes Biosulfur fluid, that is highest effectiveness for the scalp.

OTC - PURPOSE SECTION

This fromula includes the active ingredient containing the highest effectiveness for the scalp called greasy dandruff

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

This product must be keep out reach of children

INDICATIONS & USAGE SECTION

This product is for topical application. Wash the hair with the shampoo in the shower

WARNINGS SECTION

If this product is contact with eyes rinse immediately with water and consult your doctor.

DOSAGE & ADMINISTRATION SECTION

To wash daily during 8 or 10 weeks, soon interdaily use until the remission of the problem. The product is for topical application.

INACTIVE INGREDIENT SECTION

Its components make it tolerable for daily use or washing the scalp affected

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMAGE OF THE LABEL IMAGE OF THE LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66854-021-01	2019-11-13	C162847	48780-1	97449f38-d592-f6ea-e053-dbdaa90aa703	SPAI-SONS SHAMPOO ACIDO ANTI-CASPA / ACID SHAMPOO ANTI-DANDRUFF
66854-021-02	2019-11-13	C162847	48780-1	97449f38-d592-f6ea-e053-dbdaa90aa703	SPAI-SONS SHAMPOO ACIDO ANTI-CASPA / ACID SHAMPOO ANTI-DANDRUFF
66854-021-03	2019-11-13	C162847	48780-1	97449f38-d592-f6ea-e053-dbdaa90aa703	SPAI-SONS SHAMPOO ACIDO ANTI-CASPA / ACID SHAMPOO ANTI-DANDRUFF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66854-021-01	SPAI-SONSACID ANTI-DANDRUFF	210 mL in 1 BOTTLE	SHAMPOO	210	1
66854-021-02	SPAI-SONSACID ANTI-DANDRUFF	250 mL in 1 BOTTLE	SHAMPOO	250	1
66854-021-03	SPAI-SONSACID ANTI-DANDRUFF	250 mL in 1 BOTTLE	SHAMPOO	250	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66854-021	SPAI-SONS ACID ANTI-DANDRUFF (SULFUR) SHAMPOO [SPAI-SONS PHARAMCUETICAL INTERNATIONAL COSMETICS]	1	Legacy NDC, 3 package rows	20120630_aaed59f5-ec35-440c-9a2b-d774629e0e20.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SULFUR	ACTIVE INGREDIENT	70FD1KFU70	1
SULFUR	ACTIVE MOIETY	70FD1KFU70	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	1
COCO MONOETHANOLAMIDE	INACTIVE INGREDIENT	C80684146D	1
DIPYRITHIONE	INACTIVE INGREDIENT	9L87N86R9A	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	1
GLYCOL DISTEARATE	INACTIVE INGREDIENT	13W7MDN21W	1
LAURETH-10	INACTIVE INGREDIENT	BD7AST04GA	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	1
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

SPAI-SONS ACID ANTI-DANDRUFF
SULFUR
WATER
SODIUM LAURETH SULFATE
COCAMIDOPROPYL BETAINE
GLYCOL DISTEARATE
COCO MONOETHANOLAMIDE
LAURETH-10
DIPYRITHIONE
PANTHENOL
POLYSORBATE 80
TROLAMINE
CITRIC ACID MONOHYDRATE
METHYLPARABEN
PROPYLPARABEN
SODIUM CHLORIDE
FD&C RED NO. 40
FD&C YELLOW NO. 5

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66854-021	66854-021-01, 66854-021-02, 66854-021-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SULFUR	70FD1KFU70	ACTIB
WATER	059QF0KO0R	IACT
SODIUM LAURETH SULFATE	BPV390UAP0	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
GLYCOL DISTEARATE	13W7MDN21W	IACT
SODIUM LAURETH SULFATE	BPV390UAP0	IACT
SODIUM LAURETH SULFATE	BPV390UAP0	IACT
COCO MONOETHANOLAMIDE	C80684146D	IACT
LAURETH-10	BD7AST04GA	IACT
DIPYRITHIONE	9L87N86R9A	IACT
PANTHENOL	WV9CM0O67Z	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
TROLAMINE	9O3K93S3TK	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 5	I753WB2F1M	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 9 · 525 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION, CONCENTRATE / INTRAVENOUS	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SPRAY, METERED / NASAL		36 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / BUCCAL	0.01 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAVENOUS		6320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRATHECAL		131 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, CHEWABLE / ORAL	7 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 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
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	CAPSULE / ORAL	652 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM / VAGINAL		56 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TRANSDERMAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	LIQUID / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / TOPICAL	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRASYNOVIAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRADERMAL	7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	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
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED / ORAL	0.04 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EFFERVESCENT / ORAL	460 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SPRAY / NASAL		30 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	ENEMA / RECTAL	0.7 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	8 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ENDOTRACHEAL	46.76 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, EXTENDED RELEASE / ORAL	2.03 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LOTION / TOPICAL	15 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL		4 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ELIXIR / ORAL	2.5 mg/15ml		Exact identifier — unii candidate 78 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / RECTAL		7 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SOLUTION / OPHTHALMIC	0.9 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 28 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
e8a9a451-b8b7-4ed3-8ca9-26ac2aee1bd1			aaed59f5-ec35-440c-9a2b-d774629e0e20	2012-06-06	Warnings	Exact identifier spl id: e8a9a451-b8b7-4ed3-8ca9-26ac2aee1bd1 spl set id: aaed59f5-ec35-440c-9a2b-d774629e0e20

Reported adverse events (FAERS/openFDA)#

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