FDA.reportPublic FDA data

Control Dandruff Therapy

Manufacturer
Kamedis
Effective date
2023-12-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:08:29

Label at a glance#

ProductControl Dandruff Therapy
Active ingredientPYRITHIONE ZINC
Label structure3 sections

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 1.0%

Purpose

OTC - PURPOSE SECTION

Anti-Dandruff

Use

INDICATIONS & USAGE SECTION

  • helps eliminate flaking, itching and scaling associated with dandruff and seborrheic dermatitis

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the 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

Keep out 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.
  • If condition covers a large area of the body, consult your doctor before using this product.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 3 years of age and older: 
  •    apply to wet hair 
  •    gently massage into hair and scalp and leave for 2-3 minutes before thoroughly rinsing 
  •    rinse and repeat if desired 
  •    for best results use at least twice a week or as directed by your doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium laureth sulfate, water, ammonium lauryl sulfate, cocamidopropyl betaine, sodium lauroyl sarcosinate, soapberry (Sapindus mukurossi) fruit extract, salicylic acid, salt (sodium chloride), polyquaternium-10, sodium benzoate, triethanolamine, fragrance

SPL UNCLASSIFIED SECTION

Made in USA
(US and non US ingredients) Manufactured for
Kamedis Pennsylvania, 18109.

www.kamedis.com

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kamedis®
Skin Restoring Solutions

BOTANIPLEX
TECHNOLOGY

SCALP
CONTROL
Dandruff Therapy
Shampoo

PYRITHIONE ZINC 1%

Clinically proven to remove up to
100% visible dandruff. Helps eliminate
flaking, scaling, itching, irritation and
redness associated with dandruff

DERMATOLOGIST
RECOMMENDED

Free from Parabens, Steroids,
Dyes, Sodium Lauryl Sulfate, Tar

200 mL
6.7 fl oz

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 200 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN5
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD5
209884zinc pyrithione 1 % Medicated ConditionerSY5
209884zinc pyrithione 1 % Medicated ShampooSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50718-0021-12024-02-13C16284748780-11030e364-fd4e-111a-e063-dadaa90a10e2Control - Dandruff Therapy Shampoo
50718-0021-12024-01-30C16284748780-11030e364-fd4e-111a-e063-dadaa90a10e2Control - Dandruff Therapy Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50718-0021-1Control Dandruff Therapy200 mL in 1 BOTTLESHAMPOO2005
50718-0021-1Control Dandruff Therapy1 in 1 CARTONSHAMPOO15
50718-0021-2Control Dandruff Therapy500 mL in 1 BOTTLESHAMPOO5005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50718-0021CONTROL DANDRUFF THERAPY (DANDRUFF THERAPY SHAMPOO) SHAMPOO [KAMEDIS]5Current NDC, Legacy NDC, 3 package rows20240213_2a5fc8ae-1d98-496c-a6ca-922897e3ab47.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50718-002150718-0021-1, 50718-0021-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRITHIONE ZINCR953O2RHZ5ACTIB
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SALICYLIC ACIDO414PZ4LPZIACT
SODIUM CHLORIDE451W47IQ8XIACT
SAPINDUS MUKOROSSI FRUIT66H9NW427YIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
AMMONIUM LAURETH-2 SULFATE698O4Z48G6IACT
POLYQUATERNIUM-10 (10000 MPA.S AT 2%)PI1STR9QYHIACT

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
Control Dandruff TherapyDANDRUFF THERAPY SHAMPOOKamedis2a5fc8ae-1d98-496c-a6ca-922897e3ab472023-12-18WarningsExact identifier
ndc (package): 50718-0021-2
ndc (package): 50718-0021-1
ndc (product): 50718-0021
ndc11 (package): 50718002101
ndc11 (package): 50718002102
spl id: 6820d2bc-1aaf-4bca-ae9a-d1509d8f4232
spl set id: 2a5fc8ae-1d98-496c-a6ca-922897e3ab47

Reported adverse events (FAERS/openFDA)#

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