CONTROL DANDRUFF- FREE BEARD WASH- pyrithione zinc shampoo

CONTROL Dandruff- Free Beard Wash by

Drug Labeling and Warnings

CONTROL Dandruff- Free Beard Wash by is a Otc medication manufactured, distributed, or labeled by Kamedis Inc, Biogenesis Inc, Fragrance Manufacturing Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Pyrithione Zinc 1.0%

Purpose

Anti-Dandruff

Use

Helps eliminate flaking, itching and scaling associated with dandruff and seborrheic dermatitis

Warnings

For external use only

When using this product

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

Stop use and ask a doctor if

• condition worsens or does not improve after regular use of this product as directed

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

• 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

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

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

INGREDIENTS AND APPEARANCE

CONTROL DANDRUFF- FREE BEARD WASH 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50718-0035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)
POLYQUATERNIUM-10 (10000 MPA.S AT 2%) (UNII: PI1STR9QYH)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50718-0035-1	1 in 1 CARTON	12/01/2022
1		200 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M032	12/01/2022

Labeler - Kamedis Inc (080311300)

Establishment
Name	Address	ID/FEI	Business Operations
Biogenesis Inc		069117328	MANUFACTURE(50718-0035)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc		793406000	MANUFACTURE(50718-0035)