DANDRENE- pyrithione zinc lotion

Dandrene by

Drug Labeling and Warnings

Dandrene by is a Otc medication manufactured, distributed, or labeled by Divine Skin Laboratories S.A. de C.V., A.I.G. Technologies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DANDRENE 
pyrithione zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72249-001
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 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
AMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
CETYL ESTERS WAX (UNII: D072FFP9GU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M)
ALCOHOL (UNII: 3K9958V90M)
MENTHOL (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
TRIDECETH-12 (UNII: YFY3KG5Y7O)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POLYSILICONE-15 (UNII: F8DRP5BB29)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
BENZYL BENZOATE (UNII: N863NB338G)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72249-001-01	1 in 1 BOX	10/16/2018
1		205 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		10/16/2018

Labeler - Divine Skin Laboratories S.A. de C.V. (812464196)

Establishment
Name	Address	ID/FEI	Business Operations
A.I.G. Technologies, Inc.		171837367	manufacture(72249-001) , label(72249-001)