FDA.reportPublic FDA data

Head and Shoulders Hair Thickening System

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2021-12-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:45:24

Label at a glance#

ProductHead and Shoulders Hair Thickening System with Biotin
Active ingredientPYRITHIONE ZINC
Label structure18 sections

Indications and uses

helps prevent recurrence of flaking and itching associated with dandruff.

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 1%

SPL UNCLASSIFIED SECTION

Hair Thickening

Step 1 2in1

with BIOTIN

Cleans to restore fullness to thinning hair, while helping maintain a healthy scalp.

pyrithione zinc dandruff shampoo + conditioner

Step 1: Use 2in1 to massage into wet hair and scalp. Lather and rinse.

Drug Facts

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, dimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, menthol, guar hydroxypropyltrimonium chloride,magnesium carbonate hydroxide, biotin, methylchloroisothiazolinone, methylisothiazolinone.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Hair Thickening

Step 2 Treatment

with BIOTIN

Thickens existing hair, while helping maintain a healthy scalp.

pyrithione zinc dandruff treatment

Step 2: Use treatment out of shower. Apply directly to roots and scalp.

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 0.1%

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

  • apply to affected areas one to four times daily or as directed by a doctor.
  • place package tip close to scalp on damp or dry hair and use 15 sprays to cover the entire scalp. Massage into scalp with fingertips. DO NOT rinse off.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, niacinamide, PEG-40 hydrogenated castor oil, phenoxyethanol, caffeine, bis-PEG/PPG-16/16 PEG/PPG-16/16 dimethicone, fragrance, glycerin, benzyl alcohol, menthol, acrylates/C10-30 alkyl acrylate crosspolymer, panthenol, tetrahydroxypropyl ethylenediamine, ethylhexylglycerin, mentha piperita (peppermint) oil, mentha arvensis leaf oil, biotin.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - Kit Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &
shoulders ®

HAIR THICKENING SYSTEM

WITH BIOTIN

head & shoulders

pyrithione zinc dandruff shampoo + conditioner

2in1 Hair Thickening Step 1

with Biotin

23.7 FL OZ (700 mL)

head &
shoulders ®

pyrithione zinc dandruff treatment

Treatment

Hair Thickening Step 2

with Biotin

6.7 FL OZ (200 mL)

HS1HS1HS2HS2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1858567Head & Shoulders 0.1 % Topical SprayPSN1
1043244head & shoulders 1 % Medicated ShampooPSN1
1858563zinc pyrithione 0.1 % Topical SprayPSN1
209884zinc pyrithione 1 % Medicated ShampooPSN1
1858567zinc pyrithione 1 MG/ML Topical Spray [Head & Shoulders]SBD1
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD1
1858563zinc pyrithione 1 MG/ML Topical SpraySCD1
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD1
1858567Head & Shoulders 0.1 % Topical SpraySY1
1043244Head & Shoulders 1 % Medicated ShampooSY1
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY1
1858563zinc pyrithione 0.1 % Topical SpraySY1
209884zinc pyrithione 1 % Medicated ConditionerSY1
209884zinc pyrithione 1 % Medicated ShampooSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-593-012023-01-30C16284748780-1f386c649-a285-0266-e053-dadaa90a7c1aHead and Shoulders ® Hair Thickening System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-593-01Head and Shoulders Hair Thickening Systemwith Biotin1 in 1 PACKAGE, COMBINATIONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-593HEAD AND SHOULDERS HAIR THICKENING SYSTEM WITH BIOTIN (PYRITHIONE ZINC) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Legacy NDC, 1 package rows20211203_d22c72c8-f1d0-2500-e053-2a95a90a58c6.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-59369423-593-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
WATER059QF0KO0RIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
ZINC CARBONATEEQR32Y7H0MIACT
GLYCOL DISTEARATE13W7MDN21WIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BENZOATEOJ245FE5EUIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
BIOTIN6SO6U10H04IACT
EDETOLQ4R969U9FRIACT
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
BIOTIN6SO6U10H04IACT
BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE55A74AJ3KBIACT
CAFFEINE3G6A5W338EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZYL ALCOHOLLKG8494WBHIACT
GLYCERINPDC6A3C0OXIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
PEPPERMINT OILAV092KU4JHIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
PANTHENOLWV9CM0O67ZIACT
NIACINAMIDE25X51I8RD4IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d22c72c8-f1cf-2500-e053-2a95a90a58c6d22c72c8-f1d0-2500-e053-2a95a90a58c62021-12-02WarningsExact identifier
spl id: d22c72c8-f1cf-2500-e053-2a95a90a58c6
spl set id: d22c72c8-f1d0-2500-e053-2a95a90a58c6

Reported adverse events (FAERS/openFDA)#

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