DZUL ANTI-DANDRUFF- zinc pyrithione shampoo 
Caball Sales, Inc.

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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83037-001-08

Zinc Pyrithione 1%

Anti-Dandruff

For the relief of the symptoms of dandruff.

For external use only.

Do not use on wounds or damaged skin or on a child under 12 years of age unless directed by a physician.

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Conditions worsens or does not improve after regular use of this product as directed.

If swallowed, get medical help or contact Poison Control Center right away.

Apply a small amount quantity of the product into hair and massage the scalp.
Rinse thoroughly with enough water, repeat if needed.

For best results, use at least twice a week or as directed by a doctor.

See on the bottom of the bottle for lot number and expiration date.

Water (Aqua), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Acrylates Copolymer, Cocamide MEA, Cocamidopropylamine Oxide, Caprylyl Glycol, Hexylene Glycol, Fragrance (Parfum), Polyquaternium-7, Sodium Hydroxide, Disodium EDTA, Citric Acid, Panthenol, Phenoxyethanol, FD&C Blue No.1 (CI 42090), Hexyl Cinnamal, Benzyl Salicylate, Coumarin, Alpha-Isomethyl Ionone, Geraniol, Linalool.

QUESTION OR COMMENTS?

Call (305)-900-8256

DZUL ANTI-DANDRUFF SHAMPOO

DZUL ANTIDANDRUFF SHAMPOO

DZUL ANTI-DANDRUFF 
zinc pyrithione shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83037-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
COUMARIN (UNII: A4VZ22K1WT)  
PANTHENOL (UNII: WV9CM0O67Z)  
GERANIOL (UNII: L837108USY)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83037-001-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product09/22/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM03209/22/2023
Labeler - Caball Sales, Inc. (047422138)

Revised: 9/2023
Document Id: 05e427ce-8645-343a-e063-6394a90a9089
Set id: 05e3fac4-c0ce-cbb9-e063-6294a90ac036
Version: 1
Effective Time: 20230922
 
Caball Sales, Inc.