FDA.reportPublic FDA data

Head and Shoulders Aloe Vera Soothing Relief 2in1

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:30:00

Label at a glance#

ProductHead and Shoulders Aloe Vera Soothing Relief 2in1
Active ingredientPYRITHIONE ZINC
Label structure10 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#

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

SPL UNCLASSIFIED SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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, glycol distearate, zinc carbonate, sodium chloride, fragrance, cocamidopropyl betaine, sodium xylenesulfonate, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, sodium laureth sulfate, aloe barbadensis leaf juice

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 370 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &
shoulders ®
PYRITHIONE ZINC DANDRUFF

SHAMPOO + CONDITIONER

ALOE VERA

SOOTHING RELIEF

2IN1

12.5 FL OZ (370 mL)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043244head & shoulders 1 % Medicated ShampooPSN2
209884zinc pyrithione 1 % Medicated ShampooPSN2
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD2
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD2
1043244Head & Shoulders 1 % Medicated ShampooSY2
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY2
209884zinc pyrithione 1 % Medicated ConditionerSY2
209884zinc pyrithione 1 % Medicated ShampooSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-054-37Head and Shoulders Aloe Vera Soothing Relief 2in1370 mL in 1 BOTTLE, PLASTICSHAMPOO3702

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-05484126-054-37

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
WATER059QF0KO0RIACT
ZINC CARBONATEEQR32Y7H0MIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCOL DISTEARATE13W7MDN21WIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
DIMETHICONE92RU3N3Y1OIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDEB16G315W7AIACT
SODIUM BENZOATEOJ245FE5EUIACT

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
Head and Shoulders Aloe Vera Soothing Relief 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company27ec4d49-a783-cacd-e063-6394a90adbbe2025-12-31WarningsExact identifier
ndc (package): 84126-054-37
ndc (product): 84126-054
ndc11 (package): 84126005437
spl id: 47486ea9-2ad0-ebe4-e063-6294a90a92c4
spl set id: 27ec4d49-a783-cacd-e063-6394a90adbbe

Reported adverse events (FAERS/openFDA)#

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