FDA.reportPublic FDA data

Elementz

Manufacturer
Keefe Group
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:06:24

Label at a glance#

ProductElementz
Active ingredientPYRITHIONE ZINC
Label structure13 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Pyrithione zinc 1%

OTC - PURPOSE SECTION

Purpose

Antidandruff shampoo

INDICATIONS & USAGE SECTION

Uses

helps prevent recurrence of flaking and itching associated with dandruff

WARNINGS SECTION

Warnings

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 out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions • wet hair, massage shampoo into scalp • rinse and repeat if desired • for maximum dandruff control, use at least twice a week or as directed by a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients Water, Sodium Laureth Sulfate, Cocamide DEA, Sodium Chloride, Styrene/Acrylates Copolymer, Coco-Glucoside, Polyquaternium-7, Fragrance, Tetrasodium EDTA, Magnesium Nitrate, Methylchloroisothiazolinone, Methylisothiazolinone, Magnesium Chloride, Citric Acid, Shea Butter, Sweet Almond Oil.

OTHER SAFETY INFORMATION

Warning: This product can expose you to chemicals including Cocamide DEA, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov

SPL UNCLASSIFIED SECTION

Distributed by:

Keefe Supply Company

Bridgeton, MO 63044

800-325-8998

Made in Colombia

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ELEMENTZ™

WITH MOISTURIZING ALMOND OIL & SHEA BUTTER

PYRITHIONE ZINC

DANDRUFF SHAMPOO

FOR DRY & ITCHY SCALP

15 FL OZ | 443 mL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN4
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD4
209884zinc pyrithione 1 % Medicated ConditionerSY4
209884zinc pyrithione 1 % Medicated ShampooSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51870-007-152024-01-02C16284748780-1f386c649-a713-0266-e053-dadaa90a7c1aElementz Dandruff Shampoo
51870-007-152023-01-30C16284748780-1f386c649-a713-0266-e053-dadaa90a7c1aElementz Dandruff Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51870-007-15Elementz443 mL in 1 BOTTLE, PLASTICSHAMPOO4434

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51870-007ELEMENTZ (PYRITHIONE ZINC) SHAMPOO [KEEFE GROUP]4Legacy NDC, 1 package rows20240103_8ad4a94f-8164-05b9-e053-2a95a90ac5f0.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51870-00751870-007-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM CHLORIDE02F3473H9OIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
COCO GLUCOSIDEICS790225BIACT
EDETATE SODIUM TETRAHYDRATEL13NHD21X6IACT
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCO DIETHANOLAMIDE92005F972DIACT
SODIUM CHLORIDE451W47IQ8XIACT
ALMOND OIL66YXD4DKO9IACT
SHEA BUTTERK49155WL9YIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT
MAGNESIUM NITRATE77CBG3UN78IACT

Source Document#

Source XML · Source PDF

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
0c6e78a3-3a52-8e62-e063-6294a90a902b8ad4a94f-8164-05b9-e053-2a95a90ac5f02024-01-01WarningsExact identifier
spl id: 0c6e78a3-3a52-8e62-e063-6294a90a902b
spl set id: 8ad4a94f-8164-05b9-e053-2a95a90ac5f0

Reported adverse events (FAERS/openFDA)#

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