Active ingredient

Zinc Pyrithione 1%

Purpose

Anti-dandruff

Uses

Relieves and helps prevent recurrence of scalp itch, irritation, redness, flaking and scaling associated with dandruff

Warnings

For external use only.

When using this Product: Avoid contact with 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 Poison Control Center right away

Directions

Apply to wet hair and scalp with gentle massage, leave in for 2 minutes, rinse

For best results use atleast 2 times per week or as direacted by a doctor

For maximum benefits use 4-5 times a week along with Dandrene anti-dandruff shampoo

Inactive ingredients

WATER, CETEARYL ALCOHOL, BEHENTRIMONIUM CHLORIDE, CETYL ESTERS, ALOE VERA GEL, KERATIN, HYDROLYZED KERATIN, AMODIMETHICONE, PEPPERMINT OIL, POLYSILICONE-15, MENTHOL, CETRIMONIUM CHLORIDE, SD ALCOHOL 40-B, DISODIUM EDTA, TRIDECETH-12, CAPRYLYL GLYCOL, METHYLISOTHIAZOLINONE

Product label

image description

DANDRENE ANTI-DANDRUFF CONDITIONER
zinc pyrithione lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69188-300
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
CETYL ESTERS WAX (UNII: D072FFP9GU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
KERATIN, TYPE I CYTOSKELETAL 40 (UNII: 2QD5SI65D8)
HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)
AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSILICONE-15 (UNII: F8DRP5BB29)
MENTHOL (UNII: L7T10EIP3A)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
ALCOHOL (UNII: 3K9958V90M)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TRIDECETH-12 (UNII: YFY3KG5Y7O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69188-300-07	205 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/20/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M032	12/20/2016

Labeler - DS Healthcare Group, Inc. (015504134)

Name	Address	ID/FEI	Business Operations
Establishment
A.I.G. Technologies, Inc		086365223	manufacture(69188-300)