HEAD AND SHOULDERS

Manufacturer
TERESA CECENA DBA GENESIS | Teresa Cecena | PROCTER AND GAMBLE MANUFACTURA S. DE R.L. DE C.V.
Effective date
2015-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:42:32

Label at a glance#

ProductHEAD AND SHOULDERS BREAKEGE PREVENTION
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT

PHYRITHIONE ZINC 1%

OTC - PURPOSE SECTION

PURPOSE

Anti-drandruff

USER SAFETY WARNINGS SECTION

USES

Helps prevent recurrence of flaking and itching associated with drandruff

Help prevent hair loss

WARNINGS SECTION

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

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

STOP USE AND ASK A DOCTOR IF

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

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

  • for maximun drandruff control, use every time you shampoo
  • wet hair, message onto scalp, rinse, repeat if desired
  • For best results use al least twice a week or as directed by a doctor.

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 alchohol, tocopheryl acetate, FD&C yellow No5, methylchloroisothiazolinonone, methyllisothiazolinone, FD&C blue No 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hslphslp

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

INDICATIONS & USAGE SECTION

DIRECTIONS

  • FOR MAXIMUN DRANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO
  • WET HAIR, MESSAGE ONTO SCALP, RINSE, REPEAT IF DESIRED
  • FOR BEST RESULTS USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR

DailyMed RxNorm Mappings#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69772-141-11HEAD AND SHOULDERSBREAKEGE PREVENTION1000 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO10001
69772-141-18HEAD AND SHOULDERSBREAKEGE PREVENTION1180 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO11801
69772-141-20HEAD AND SHOULDERSBREAKEGE PREVENTION200 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO2001
69772-141-40HEAD AND SHOULDERSBREAKEGE PREVENTION400 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO4001
69772-141-50HEAD AND SHOULDERSBREAKEGE PREVENTION500 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69772-141HEAD AND SHOULDERS BREAKEGE PREVENTION (PYRITHIONE ZINC 1%) LOTION/SHAMPOO [TERESA CECENA DBA GENESIS]1Legacy NDC, 5 package rows20150513_15e90836-ae23-3979-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ51
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ51
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146D1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M1
GLYCOL DISTEARATEINACTIVE INGREDIENT13W7MDN21W1
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)INACTIVE INGREDIENTB16G315W7A1
MAGNESIUM CARBONATE HYDROXIDEINACTIVE INGREDIENTYQO029V1L41
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SAB1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPN1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP01
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
WATERINACTIVE INGREDIENT059QF0KO0R1
ZINC CARBONATEINACTIVE INGREDIENTEQR32Y7H0M1

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69772-14169772-141-50, 69772-141-40, 69772-141-20, 69772-141-11, 69772-141-18

Ingredients#

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

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

Source Document#

Source XML · Source PDF

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 ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, COATED / ORAL123 mgExact identifier — unii candidate
42 equally ranked IID candidates
ZINC CARBONATEZINC CARBONATEEQR32Y7H0MINJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS1.6 mgExact identifier — unii candidate
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MLIQUID / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAVENOUS1620 mgExact identifier — unii candidate
50 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii candidate
37 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPELLET / ORAL2 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLOTION / TOPICAL4000 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / ORAL600 mgExact identifier — unii candidate
42 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MCAPSULE / ORAL652 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED PELLETS / ORAL1 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUENEMA / RECTAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO, SUSPENSION / TOPICAL40 %w/vExact identifier — unii candidate
42 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRACAVITARY0.01 mlExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPOWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
42 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAMUSCULAR54 mgExact identifier — unii candidate
50 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM / SUBLINGUAL0.07 mgExact identifier — unii candidate
37 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTERIAL0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
50 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLOTION / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, COATED / ORAL7.93 mgExact identifier — unii candidate
22 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAVENOUS45 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii candidate
35 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
37 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
42 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / RECTAL124 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPOWDER / VAGINAL3 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, FOR SUSPENSION / ORAL264 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, EMULSION / INTRAVENOUS0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / VAGINAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSYRUP / ORAL0.1 mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii candidate
37 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRASYNOVIAL18 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCREAM / VAGINAL12 mgExact identifier — unii candidate
42 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MELIXIR / ORAL0.15 mgExact identifier — unii candidate
22 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii candidate
35 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / ORAL180 mgExact identifier — unii candidate
22 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE, EXTENDED RELEASE / ORAL1.23 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, DELAYED RELEASE PELLETS / ORAL99 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SHAMPOO / TOPICAL3192 mgExact identifier — unii candidate
5 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSPRAY / NASAL5 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii candidate
35 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSPRAY / TOPICAL7 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / BUCCAL5.18 mgExact 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
15e90836-ae24-3979-e054-00144ff88e8815e90836-ae23-3979-e054-00144ff88e882015-05-12WarningsExact identifier
spl id: 15e90836-ae24-3979-e054-00144ff88e88
spl set id: 15e90836-ae23-3979-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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