DIVINE DANDRENE 2%- zinc pyrithione shampoo

Divine Dandrene 2% by

Drug Labeling and Warnings

Divine Dandrene 2% by is a Otc medication manufactured, distributed, or labeled by DS Healthcare Group, Inc., A.I.G. Technologies, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc Pyrithione 2%

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

KEEP OUT OF REACH OF CHILDREN

Directions

Apply shampoo to wet hair and scalp with gentle massage, leave in for 2-3 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 conditioner

Inactive ingredients

Water, Disodium Laureth Sulfosuccinate, Triethanolamine, Glycolic Acid, Cocamide MEA, Sodium Lauroyl Sarcosinate, Sodium Lauryl Suloacetate, Glycol Distearate, PEG-150 Distearate, Magnesium Aluminum Silicate, Sodium Citrate, Hexamidine Diisethionate, Hydrolyzed Lupine
Protein, Caprylyl Glycol, Phenoxyethanol, Butylene Glycol, Punica Granatum Extract, Rosmarinus Officinalis Leaf Extract, Shikimic Acid, Tioxolone, Blue 1

Product label

INGREDIENTS AND APPEARANCE

DIVINE DANDRENE 2% 
zinc pyrithione shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69188-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCOLIC ACID (UNII: 0WT12SX38S)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
HEXAMIDINE DIISETHIONATE (UNII: 023XA5Z50L)
SURINAMINE (UNII: AIQ58N56TM)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PUNICA GRANATUM FLOWER (UNII: D9B634V4GP)
ROSEMARY (UNII: IJ67X351P9)
SHIKIMIC ACID (UNII: 29MS2WI2NU)
TIOXOLONE (UNII: S0FAJ1R9CD)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69188-200-07	205 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	06/01/2021

Labeler - DS Healthcare Group, Inc. (015504134)

Establishment
Name	Address	ID/FEI	Business Operations
A.I.G. Technologies, Inc		086365223	manufacture(69188-200)