Head and Shoulders

Manufacturer: ALL NATURAL DYNAMICS | Procter & Gamble Manufactura, S. de R.L. de C.V.
Effective date: 2013-02-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:34:25

Label at a glance#

ProductHead and Shoulders breakage prevention

Active ingredientPyrithione Zinc

Label structure9 sections

Indications and uses

helps prevent recurrence of flaking and itching associated with dandruff. helps prevent hair loss

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.

helps prevent hair loss

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, Coco Monoethanolamide, Zinc carbonate, Glycol distearate, Dimethicone, Guar hydroxypropyltrimonium chloride, Magnesium sulfate, Sodium benzoate, Magnesium carbonate hydroxide, Benzyl alcohol, Tocopheryl acetate, FD&C Yellow No. 5, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Blue no. 1

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51769-141-01	2019-11-27	C162847	48780-1	9855d018-eec1-cd31-e053-dbdaa90ab51a	Head and Shoulders breakage prevention
51769-141-05	2019-11-27	C162847	48780-1	9855d018-eec1-cd31-e053-dbdaa90ab51a	Head and Shoulders breakage prevention
51769-141-11	2019-11-27	C162847	48780-1	9855d018-eec1-cd31-e053-dbdaa90ab51a	Head and Shoulders breakage prevention
51769-141-18	2019-11-27	C162847	48780-1	9855d018-eec1-cd31-e053-dbdaa90ab51a	Head and Shoulders breakage prevention
51769-141-20	2019-11-27	C162847	48780-1	9855d018-eec1-cd31-e053-dbdaa90ab51a	Head and Shoulders breakage prevention
51769-141-40	2019-11-27	C162847	48780-1	9855d018-eec1-cd31-e053-dbdaa90ab51a	Head and Shoulders breakage prevention
51769-141-50	2019-11-27	C162847	48780-1	9855d018-eec1-cd31-e053-dbdaa90ab51a	Head and Shoulders breakage prevention

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51769-141-01	Head and Shouldersbreakage prevention	10 mL in 1 POUCH	SHAMPOO	10	1
51769-141-05	Head and Shouldersbreakage prevention	50 mL in 1 BOTTLE, PLASTIC	SHAMPOO	50	1
51769-141-11	Head and Shouldersbreakage prevention	1000 mL in 1 BOTTLE, PLASTIC	SHAMPOO	1000	1
51769-141-18	Head and Shouldersbreakage prevention	1180 mL in 1 BOTTLE, PLASTIC	SHAMPOO	1180	1
51769-141-20	Head and Shouldersbreakage prevention	200 mL in 1 BOTTLE, PLASTIC	SHAMPOO	200	1
51769-141-40	Head and Shouldersbreakage prevention	400 mL in 1 BOTTLE, PLASTIC	SHAMPOO	400	1
51769-141-50	Head and Shouldersbreakage prevention	500 mL in 1 BOTTLE, PLASTIC	SHAMPOO	500	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51769-141	HEAD AND SHOULDERS BREAKAGE PREVENTION (PYRITHIONE ZINC) SHAMPOO [ALL NATURAL DYNAMICS]	1	Legacy NDC, 7 package rows	20130202_35efb2a7-b707-4fe1-9a45-0b280aac7618.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
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
Benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	1
Coco Monoethanolamide	INACTIVE INGREDIENT	C80684146D	1
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	1
FD&C Blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C Yellow No. 5	INACTIVE INGREDIENT	I753WB2F1M	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 laureth sulfate	INACTIVE INGREDIENT	BPV390UAP0	1
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	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 breakage prevention
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
Benzyl alcohol
.ALPHA.-TOCOPHEROL ACETATE
FD&C Yellow No. 5
methylchloroisothiazolinone
methylisothiazolinone
FD&C Blue no. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51769-141	51769-141-50, 51769-141-40, 51769-141-20, 51769-141-11, 51769-141-18, 51769-141-05, 51769-141-01

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
Benzyl alcohol	LKG8494WBH	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
FD&C Yellow No. 5	I753WB2F1M	IACT
methylchloroisothiazolinone	DEL7T5QRPN	IACT
methylisothiazolinone	229D0E1QFA	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 4 · 202 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C Blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, FILM COATED / ORAL	0.16 mg		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
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRALESIONAL		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 22 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
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	SPRAY, METERED / NASAL	5 mg/1ml		Exact identifier — unii candidate 50 equally ranked IID candidates
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	SHAMPOO / TOPICAL	1.25 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
Sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS		18 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, FILM COATED / ORAL	1.68 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
Sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	GEL / VAGINAL	0.2 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SUBCUTANEOUS		90 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
FD&C Blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / ORAL	1.13 mg/15ml		Exact identifier — unii candidate 37 equally ranked IID candidates
Sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EXTENDED RELEASE / ORAL		320 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	INJECTION, EMULSION / INTRAVENOUS	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAVENOUS		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	LOTION / TOPICAL		4000 mg	Exact identifier — unii candidate 50 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 lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET / ORAL	30 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / BUCCAL	0.11 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
Sodium laureth sulfate	SODIUM LAURETH-3 SULFATE	BPV390UAP0	SHAMPOO / TOPICAL		3192 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
Sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	INJECTION, SOLUTION / INTRAMUSCULAR	4.8 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	CREAM / TOPICAL		160 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / SUBCUTANEOUS		225 mg	Exact identifier — unii candidate 50 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
Sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	LOTION / TOPICAL		111 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
FD&C Blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	MOUTHWASH / BUCCAL	NA		Exact identifier — unii candidate 37 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
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRA-ARTICULAR	1 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRALESIONAL		20 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Sodium laureth sulfate	SODIUM LAURETH-3 SULFATE	BPV390UAP0	CREAM / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
Sodium laureth sulfate	SODIUM LAURETH-3 SULFATE	BPV390UAP0	TABLET / ORAL	0.91 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
FD&C Blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	CONCENTRATE / BUCCAL	NA		Exact identifier — unii candidate 22 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
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / ORAL		100 mg	Exact identifier — unii candidate 50 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
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	LIQUID / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	TABLET / ORAL	1.06 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
Sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION, EXTENDED RELEASE / ORAL	0.08 mg/1ml		Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	PASTE / DENTAL	1.5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING / ORAL		16 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Magnesium sulfate	MAGNESIUM SULFATE	DE08037SAB	CAPSULE / ORAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRACAVITARY	0.01 ml		Exact identifier — unii candidate 50 equally ranked IID candidates
FD&C Blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	ELIXIR / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
Sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, DELAYED RELEASE / ORAL		199 mg	Exact identifier — unii candidate 42 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 lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	GRANULE / ORAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	SPONGE / TOPICAL	5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRA-ARTERIAL	0.9 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
Sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED PELLETS / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
Benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	CAPSULE, EXTENDED RELEASE / ORAL	1.23 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / ORAL	180 mg		Exact identifier — unii candidate 22 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
Magnesium sulfate	MAGNESIUM SULFATE	DE08037SAB	TABLET / ORAL	2.9 mg		Exact identifier — unii candidate 6 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
f58016ec-c5ab-4943-bd2b-e85b04fac313			35efb2a7-b707-4fe1-9a45-0b280aac7618	2013-02-01	Warnings	Exact identifier spl id: f58016ec-c5ab-4943-bd2b-e85b04fac313 spl set id: 35efb2a7-b707-4fe1-9a45-0b280aac7618

Reported adverse events (FAERS/openFDA)#

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