CONTROL DANDRUFF THERAPY- dandruff therapy shampoo shampoo

Control Dandruff Therapy by

Drug Labeling and Warnings

Control Dandruff Therapy by is a Otc medication manufactured, distributed, or labeled by Kamedis. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Pyrithione Zinc 1.0%

Purpose

Anti-Dandruff

Use

• Helps eliminate scalp itching, irritation, redness, flaking, and scaling associated with dandruff

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

• If condition worsens or does not improve after regular use of this product as directed, consult a doctor

Keep out of reach of children

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

Directions

• 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

Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Fragrance, Polyquaternium-10, Salicylic Acid, Salt(Sodium Chloride), Soapberry (Sapindus Mukurossi) Fruit Extract, Sodium Benzoate, Sodium Lauroyl Sarcosinate, Triethanolamine, Water.

Questions or Comments?

1-855-626-6606

SPL UNCLASSIFIED SECTION

Made in USA
Manufactured for Kamedis, Pennsylvania 18109
1-855-626-6606

www.kamedis-usa.com

Carton label

INGREDIENTS AND APPEARANCE

CONTROL DANDRUFF THERAPY 
dandruff therapy shampoo shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50718-0021
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)
TROLAMINE (UNII: 9O3K93S3TK)
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)
POLYQUATERNIUM-10 (10000 MPA.S AT 2%) (UNII: PI1STR9QYH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50718-0021-1	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/01/2018

Labeler - Kamedis (533176319)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing, Inc.		793406000	manufacture(50718-0021)