NDC Code(s) : 50718-0021-1, 50718-0021-2
Packager : Kamedis

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Control Dandruff Therapydandruff therapy shampoo SHAMPOO
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50718-0021
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC(UNII: R953O2RHZ5)
(PYRITHIONE ZINC - UNII:R953O2RHZ5) 		PYRITHIONE ZINC10 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
1NDC:50718-0021-11 in 1 CARTON 01/01/2018
1200 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:50718-0021-2500 mL in 1 BOTTLE Type 0: Not a Combination Product01/01/2024
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph drug M032 01/01/2018

LABELER - Kamedis(080311300)

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