FDA.reportPublic FDA data

CONTROL Dandruff- Free Beard Wash

Manufacturer
Kamedis Inc | Biogenesis Inc | Fragrance Manufacturing Inc
Effective date
2023-11-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:03:33

Label at a glance#

ProductCONTROL Dandruff- Free Beard Wash
Active ingredientPYRITHIONE ZINC
Label structure8 sections

Dosage and administration

adults and children 3 years of age and older: apply to wet beard or hair gently massage into beard, 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

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.
  • 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 beard or hair
    • gently massage into beard, 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

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kamedis®
Skin Restoring Solutions

BOTANIPLEX
TECHNOLOGY

CONTROL
Dandruff Free
Beard Wash

PYRITHIONE ZINC 1%
Prevents and fights beard flaking.
Relieves irritation redness and
itchiness associated with dandruff.
Leaves the beard shiny and smooth

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 ShampooPSN2
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD2
209884zinc pyrithione 1 % Medicated ConditionerSY2
209884zinc pyrithione 1 % Medicated ShampooSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50718-0035-1CONTROL Dandruff- Free Beard Wash200 mL in 1 BOTTLESHAMPOO2002
50718-0035-1CONTROL Dandruff- Free Beard Wash1 in 1 CARTONSHAMPOO12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50718-0035CONTROL DANDRUFF- FREE BEARD WASH (PYRITHIONE ZINC) SHAMPOO [KAMEDIS INC]2Current NDC, Legacy NDC, 2 package rows20231207_d9f58a4d-d53a-4965-ac5c-67c2ce4947ee.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50718-003550718-0035-1

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
AMMONIUM LAURETH-2 SULFATE698O4Z48G6IACT
POLYQUATERNIUM-10 (10000 MPA.S AT 2%)PI1STR9QYHIACT
TROLAMINE9O3K93S3TKIACT

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- Free Beard WashPYRITHIONE ZINCKamedis Incd9f58a4d-d53a-4965-ac5c-67c2ce4947ee2023-11-27WarningsExact identifier
ndc (package): 50718-0035-1
ndc (product): 50718-0035
ndc11 (package): 50718003501
spl id: db32e987-fff4-4e09-b00a-a42b3a0b869e
spl set id: d9f58a4d-d53a-4965-ac5c-67c2ce4947ee

Reported adverse events (FAERS/openFDA)#

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