DANDRENE- pyrithione zinc shampoo

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]

​Active ingredient

Pyrithione zinc 2% w/w

​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

​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

​Keep out of reach of children.  ​If swallowed, get medical help or contact Poison Control Center right away.

​Directions

Apply shampoo to wet hair and scalp with a gentle massage, leave in for 2-3 minutes, rinse.

For best results use at least 2 times per week or as directed by a doctor.

For maximum benefit use 4-5 times a week along with Dandrene Anti-Dandruff Conditioner.

​Inactive ingredients

Water, Sodium Lauryl Sulfoacetate, Disodium Laureth Sulfosuccinate, Sodium Lauroyl Sarcosinate, Triethanolamine, Glycolic Acid, Cocamide MEA, Glyceryl Stearate, PEG-150 Distearate, Magnesium Aluminum Silicate, Sodium Citrate, Hexamidine Diisethionate, Hydrolyzed Lupine Protein, Caprylyl Glycol, Phenoxyethanol, Butylene Glycol, Pomegranage Peel (Punica Granutum) Extract, Rosemary (Rosmarinus Officinalis) Leaf Extract, Shikimic Acid, Tioxolone, Emu Oil, Fragrance, Blue 1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DANDRENE 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72249-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCOLIC ACID (UNII: 0WT12SX38S)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
HEXAMIDINE DIISETHIONATE (UNII: 023XA5Z50L)
LUPINUS ALBUS SEED (UNII: 24GB753W3B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POMEGRANATE FRUIT RIND (UNII: RS999V57DU)
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)
SHIKIMIC ACID (UNII: 29MS2WI2NU)
TIOXOLONE (UNII: S0FAJ1R9CD)
EMU OIL (UNII: 344821WD61)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72249-100-01	1 in 1 BOX	10/01/2018
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
OTC monograph final	part358H	05/01/2018

Labeler - DIVINE SKIN LABORATORIES S.A. de C.V. (812464196)

Establishment
Name	Address	ID/FEI	Business Operations
A.I.G. Technologies, Inc.		171837367	manufacture(72249-100) , label(72249-100) , pack(72249-100)