SPAI-SONS

Manufacturer: SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS
Effective date: 2012-06-05
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:32:27

Label at a glance#

ProductSPAI-SONS ALKALINE DRY-DANDRUFF

Active ingredientPYRITHIONE ZINC

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

This formula includes Zinc Pyrithione used to eliminate the agent causing dry dandruff and scalp drying.

OTC - PURPOSE SECTION

USE: Hair washing and scalp affected by exfoliation, scales and dry 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 appplication. 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. This product is for topical application

INACTIVE INGREDIENT SECTION

This composition moisturizes and lubricate capillary dermis

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
66854-017-01	2019-11-13	C162847	48780-1	97449f38-bc42-f6ea-e053-dbdaa90aa703	SPAI-SONS SHAMPOO ALCALINO ANTI CASPA SECA / ALKALINE SHAMPOO DRY-DANDRUFF
66854-017-02	2019-11-13	C162847	48780-1	97449f38-bc42-f6ea-e053-dbdaa90aa703	SPAI-SONS SHAMPOO ALCALINO ANTI CASPA SECA / ALKALINE SHAMPOO DRY-DANDRUFF
66854-017-03	2019-11-13	C162847	48780-1	97449f38-bc42-f6ea-e053-dbdaa90aa703	SPAI-SONS SHAMPOO ALCALINO ANTI CASPA SECA / ALKALINE SHAMPOO DRY-DANDRUFF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66854-017-01	SPAI-SONS ALKALINE DRY-DANDRUFF	210 mL in 1 BOTTLE	SHAMPOO	210	1
66854-017-02	SPAI-SONS ALKALINE DRY-DANDRUFF	250 mL in 1 BOTTLE	SHAMPOO	250	1
66854-017-03	SPAI-SONS ALKALINE DRY-DANDRUFF	400 mL in 1 BOTTLE	SHAMPOO	400	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66854-017	SPAI-SONS ALKALINE DRY-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1	Legacy NDC, 3 package rows	20120630_d47c1035-a4b1-4732-86ee-e7d6670a94e3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PYRITHIONE ZINC	ACTIVE INGREDIENT	R953O2RHZ5	1
PYRITHIONE ZINC	ACTIVE MOIETY	R953O2RHZ5	1
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	1
DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE	INACTIVE INGREDIENT	1R81RPY10G	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
PEG-120 METHYL GLUCOSE DIOLEATE	INACTIVE INGREDIENT	YM0K64F20V	1
PONCEAU 4R	INACTIVE INGREDIENT	Z525CBK9PG	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 · 13 matching rows.

SPAI-SONS ALKALINE DRY-DANDRUFF
PYRITHIONE ZINC
WATER
SODIUM LAURETH SULFATE
DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE
COCO DIETHANOLAMIDE
TROLAMINE
PEG-120 METHYL GLUCOSE DIOLEATE
SODIUM CHLORIDE
METHYLPARABEN
PROPYLPARABEN
PONCEAU 4R
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66854-017	66854-017-01, 66854-017-02, 66854-017-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PYRITHIONE ZINC	R953O2RHZ5	ACTIM
WATER	059QF0KO0R	IACT
SODIUM LAURETH SULFATE	BPV390UAP0	IACT
DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE	1R81RPY10G	IACT
COCO DIETHANOLAMIDE	92005F972D	IACT
TROLAMINE	9O3K93S3TK	IACT
PEG-120 METHYL GLUCOSE DIOLEATE	YM0K64F20V	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
PONCEAU 4R	Z525CBK9PG	IACT
FD&C BLUE NO. 1	H3R47K3TBD	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 · 351 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVASCULAR	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, DELAYED RELEASE / ORAL		97 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	JELLY / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 37 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	SOLUTION / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SHAMPOO / TOPICAL		600 mg	Exact identifier — unii candidate 5 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	GEL / OPHTHALMIC	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL, METERED / TRANSDERMAL		14 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	IMPLANT / SUBCUTANEOUS	77 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / SUBCUTANEOUS	0.7 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERIDURAL	8.07 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVITREAL	10 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	226 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 134 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	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SOLUTION / ORAL	0.04 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / VAGINAL	10 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 79 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
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ORAL		98 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 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
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAVENOUS		6320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAMUSCULAR		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SHAMPOO / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	CAPSULE / ORAL	3.5 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	DROPS / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	15 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, FOAM / TOPICAL	2.6 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PARENTERAL		584 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / ORAL		148 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / NASAL	7.4 mg/1ml		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / OPHTHALMIC		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TRANSDERMAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRADERMAL	1 mg		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
0e71594b-a004-44cb-a8ae-f76ee1b1db4b			d47c1035-a4b1-4732-86ee-e7d6670a94e3	2012-06-05	Warnings	Exact identifier spl id: 0e71594b-a004-44cb-a8ae-f76ee1b1db4b spl set id: d47c1035-a4b1-4732-86ee-e7d6670a94e3

Reported adverse events (FAERS/openFDA)#

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