DANDRENE- pyrithione zinc shampoo 
DIVINE SKIN LABORATORIES S.A. de C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dandrene Anti-Dandruff Shampoo

​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 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 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

boxlabel

DANDRENE 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72249-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72249-100-011 in 1 BOX10/01/2018
1205 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H05/01/2018
Labeler - DIVINE SKIN LABORATORIES S.A. de C.V. (812464196)
Establishment
NameAddressID/FEIBusiness Operations
A.I.G. Technologies, Inc.086365223manufacture(72249-100) , label(72249-100) , pack(72249-100)

Revised: 11/2020
Document Id: d560e0d3-bbe5-4a35-8fc8-873f03485bd6
Set id: 3be1c394-2a9b-447b-90c8-422a1e483f0c
Version: 2
Effective Time: 20201130
 
DIVINE SKIN LABORATORIES S.A. de C.V.