HEAD AND SHOULDERS 3 IN 1 MEN

Manufacturer
ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V. | PROCTER & GAMBLE MANUFACTURING MEXICO, S. DE R.L. DE C.V.
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:55

Label at a glance#

ProductHEAD AND SHOULDERS 3 IN 1 MEN
Active ingredientPYRITHIONE ZINC
Label structure11 sections

Dosage and administration

-shake well before use - apply in wet hair - massage into scalp - rinse -repeat as desired -for best results use at least twice a week or as directed by a doctor -for maximum dandruff control, use every time you shampoo

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Deeply Cleanses 3 Action formula TM

Protects hair against dandruff

Softens hair

*Up to 100% dandruff free

With Regular use, H&S 3action formula cleans, protects and hydrates hair and scalf.

The DermaSense balanced pH formula, eliminates up to 100% of dandruff trace*, takes care of your scalp and leaves your hair

beautiful,

*Visible dandruff, using it often.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient................................................................................Purpose

Pyrithione Zinc 1%.....................................................................Anti-dandruff

Warnings

WARNINGS SECTION

for external use only.

When using this product

OTC - WHEN USING SECTION

-do not get into eyes. If contact occurs, rinse thoroughly with water

Stop use and ask doctor if

OTC - STOP USE SECTION

condition worsens or does not improve after regular use as directed

Keep our of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

-shake well before use - apply in wet hair - massage into scalp - rinse

-repeat as desired

-for best results use at least twice a week or as directed by a doctor

-for maximum dandruff control, use every time you shampoo

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, sodium laureth sulfate, sodium laurylsulfate, dimethicone, cocamide MEA, zinc carbonate, glycol distearate,

sodium xylenesulfonate, fragrance, cetyl alcohol,

guarhydroxypropyltrimonium chloride, hydrochloric acid,, magnesium sulfate, sodium chloride,sodium benzoate,limonene,

linalool, magnesium carbonate hydroxide, benzyl alcohol, methylchloroisothiazolinone,

FD&C Blue 1, methylisothiaolinone, D&C Red No 33

Distributed by:

OTC - QUESTIONS SECTION

ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V.

Made in Mexico

Indications:

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking and itching associated with dandruff

Principal Display Panel Antidandruff Shampoo 3 in 1 MEN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antidandruff Shampoo 3 in 1
MEN

Antidandruff Shampoo 3 in 1 MENAntidandruff Shampoo 3 in 1 MEN

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
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72389-106-022024-01-30C16284748780-11030e365-0ef5-111a-e063-dadaa90a10e2Head and Shoulders 3 in 1 MEN
72389-106-032024-01-30C16284748780-11030e365-0ef5-111a-e063-dadaa90a10e2Head and Shoulders 3 in 1 MEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72389-106-02HEAD AND SHOULDERS 3 IN 1 MEN375 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO3752
72389-106-03HEAD AND SHOULDERS 3 IN 1 MEN180 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72389-106HEAD AND SHOULDERS 3 IN 1 MEN (HEAD AND SHOULDERS) LOTION/SHAMPOO [ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V.]2Legacy NDC, 2 package rows20220115_76e4f214-2c11-b8ff-e053-2991aa0a6c0b.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72389-10672389-106-02, 72389-106-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

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
d58e9a2a-afc3-3f27-e053-2a95a90a34ab76e4f214-2c11-b8ff-e053-2991aa0a6c0b2022-01-14WarningsExact identifier
spl id: d58e9a2a-afc3-3f27-e053-2a95a90a34ab
spl set id: 76e4f214-2c11-b8ff-e053-2991aa0a6c0b

Reported adverse events (FAERS/openFDA)#

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