Head and Shoulders

Manufacturer: ALL NATURAL DYNAMICS | Procter & Gamble Manufactura, S. de R.L. de C.V.
Effective date: 2013-01-29
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:34:22

Label at a glance#

ProductHead and Shoulders renewing clean

Active ingredientPyrithione Zinc

Label structure9 sections

Indications and uses

helps prevent recurrence of flaking and itching associated with dandruff.

Dosage and administration

for maximum dandruff control, use every time you shampoo. wet hair, massage onto scalp, rinse, repeat if desired. for best results use at least twice a week or as directed by a doctor.

Contacts and useful links#

PhoneLabel contact800-717-2413

Websitewww.headandshoulders.com

www.headandshoulders.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Uses

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens or does not improve after regular use of this product as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

for maximum dandruff control, use every time you shampoo.
wet hair, massage onto scalp, rinse, repeat if desired.
for best results use at least twice a week or as directed by a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, sodium laureth sulfate, sodium lauryl sulfate, cocamide MEA, zinc carbonate, glycol distearate, dimethicone, fragrance, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, blue 1, D&C red 33.

Questions (or comments)?

OTC - QUESTIONS SECTION

01-800-717-2413

SPL UNCLASSIFIED SECTION

Dist. by

Procter & Gamble Manufactura, S. de R.L. de C.V.

San Andr`s Atoto No. 326, Naucalpan de Juarez,

Estado de Mexico, MX

www.headandshoulders.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1043244	head & shoulders 1 % Medicated Shampoo	PSN	1
209884	zinc pyrithione 1 % Medicated Shampoo	PSN	1
1043244	zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]	SBD	1
209884	zinc pyrithione 10 MG/ML Medicated Shampoo	SCD	1
1043244	Head & Shoulders 1 % Medicated Shampoo	SY	1
1043244	Head & Shoulders 10 MG/ML Medicated Shampoo	SY	1
209884	zinc pyrithione 1 % Medicated Conditioner	SY	1
209884	zinc pyrithione 1 % Medicated Shampoo	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51769-139-01	2019-11-27	C162847	48780-1	9855d018-e08d-cd31-e053-dbdaa90ab51a	Head and Shoulders renewing clean
51769-139-05	2019-11-27	C162847	48780-1	9855d018-e08d-cd31-e053-dbdaa90ab51a	Head and Shoulders renewing clean
51769-139-11	2019-11-27	C162847	48780-1	9855d018-e08d-cd31-e053-dbdaa90ab51a	Head and Shoulders renewing clean
51769-139-18	2019-11-27	C162847	48780-1	9855d018-e08d-cd31-e053-dbdaa90ab51a	Head and Shoulders renewing clean
51769-139-20	2019-11-27	C162847	48780-1	9855d018-e08d-cd31-e053-dbdaa90ab51a	Head and Shoulders renewing clean
51769-139-40	2019-11-27	C162847	48780-1	9855d018-e08d-cd31-e053-dbdaa90ab51a	Head and Shoulders renewing clean
51769-139-50	2019-11-27	C162847	48780-1	9855d018-e08d-cd31-e053-dbdaa90ab51a	Head and Shoulders renewing clean
51769-139-70	2019-11-27	C162847	48780-1	9855d018-e08d-cd31-e053-dbdaa90ab51a	Head and Shoulders renewing clean

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51769-139-01	Head and Shouldersrenewing clean	10 mL in 1 POUCH	LOTION/SHAMPOO	10	1
51769-139-05	Head and Shouldersrenewing clean	50 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	50	1
51769-139-11	Head and Shouldersrenewing clean	1000 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	1000	1
51769-139-18	Head and Shouldersrenewing clean	1180 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	1180	1
51769-139-20	Head and Shouldersrenewing clean	200 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	200	1
51769-139-40	Head and Shouldersrenewing clean	400 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	400	1
51769-139-50	Head and Shouldersrenewing clean	500 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	500	1
51769-139-70	Head and Shouldersrenewing clean	700 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	700	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51769-139	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1	Legacy NDC, 8 package rows	20130130_d5d3eea1-e97d-4d63-9329-35e38ece507a.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 Monoethanolamide	INACTIVE INGREDIENT	C80684146D	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	1
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
glycol distearate	INACTIVE INGREDIENT	13W7MDN21W	1
guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide)	INACTIVE INGREDIENT	B16G315W7A	1
magnesium carbonate hydroxide	INACTIVE INGREDIENT	YQO029V1L4	1
magnesium sulfate	INACTIVE INGREDIENT	DE08037SAB	1
methylchloroisothiazolinone	INACTIVE INGREDIENT	DEL7T5QRPN	1
methylisothiazolinone	INACTIVE INGREDIENT	229D0E1QFA	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	1
sodium laureth sulfate	INACTIVE INGREDIENT	BPV390UAP0	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	1
sodium xylenesulfonate	INACTIVE INGREDIENT	G4LZF950UR	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1
zinc carbonate	INACTIVE INGREDIENT	EQR32Y7H0M	1

Products#

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

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

Head and Shoulders renewing clean
Pyrithione Zinc
Water
sodium laureth sulfate
sodium lauryl sulfate
Coco Monoethanolamide
zinc carbonate
glycol distearate
dimethicone
guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide)
magnesium sulfate
sodium benzoate
magnesium carbonate hydroxide
sodium chloride
methylchloroisothiazolinone
methylisothiazolinone
sodium xylenesulfonate
FD&C blue no. 1
D&C RED NO. 33

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51769-139	51769-139-40, 51769-139-50, 51769-139-20, 51769-139-70, 51769-139-11, 51769-139-18, 51769-139-05, 51769-139-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Pyrithione Zinc	R953O2RHZ5	ACTIB
Water	059QF0KO0R	IACT
sodium laureth sulfate	BPV390UAP0	IACT
sodium lauryl sulfate	368GB5141J	IACT
Coco Monoethanolamide	C80684146D	IACT
zinc carbonate	EQR32Y7H0M	IACT
glycol distearate	13W7MDN21W	IACT
dimethicone	92RU3N3Y1O	IACT
guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide)	B16G315W7A	IACT
magnesium sulfate	DE08037SAB	IACT
sodium benzoate	OJ245FE5EU	IACT
magnesium carbonate hydroxide	YQO029V1L4	IACT
sodium chloride	451W47IQ8X	IACT
methylchloroisothiazolinone	DEL7T5QRPN	IACT
methylisothiazolinone	229D0E1QFA	IACT
sodium xylenesulfonate	G4LZF950UR	IACT
FD&C blue no. 1	H3R47K3TBD	IACT
D&C RED NO. 33	9DBA0SBB0L	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 5 · 275 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	INJECTION, SOLUTION / INTRAVENOUS		2916 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii candidate 134 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
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE, LIQUID FILLED / ORAL	0.01 mg		Exact identifier — unii candidate 14 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
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVENOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	SYRUP / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SPRAY / NASAL		30 mg	Exact identifier — unii candidate 134 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
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	GRANULE, FOR SUSPENSION / ORAL		162 mg	Exact identifier — unii candidate 134 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	DROPS / OPHTHALMIC	0.08 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INHALANT / RESPIRATORY (INHALATION)	3 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RESPIRATORY (INHALATION)		108 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	GRANULE / ORAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	ELIXIR / ORAL	27.5 mg/5ml		Exact identifier — unii candidate 14 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	OINTMENT / TOPICAL		14 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	DOUCHE / VAGINAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	DROPS / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUPPOSITORY / RECTAL		140 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
magnesium sulfate	MAGNESIUM SULFATE	DE08037SAB	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERIDURAL	8.07 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / PARENTERAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	GEL / VAGINAL	10 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL		11 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET / SUBLINGUAL	1.1 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, EXTENDED RELEASE / ORAL		166 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER, DENTIFRICE / DENTAL	0.03 mg/mg		Exact identifier — unii candidate 134 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	SOLUTION / INTRAMUSCULAR		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	SPRAY / TOPICAL		7 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAVITARY	0.82 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FOR SUSPENSION / ORAL		264 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CREAM / TOPICAL		214 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	PELLET / ORAL		2 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVENOUS		28773 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
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, DELAYED RELEASE / ORAL	0.34 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FILM COATED / ORAL		240 mg	Exact identifier — unii candidate 42 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
bee61e39-5dbe-4dc0-b6bd-d753fe128346			d5d3eea1-e97d-4d63-9329-35e38ece507a	2013-01-29	Warnings	Exact identifier spl id: bee61e39-5dbe-4dc0-b6bd-d753fe128346 spl set id: d5d3eea1-e97d-4d63-9329-35e38ece507a

Reported adverse events (FAERS/openFDA)#

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