DANDRUFF- pyrithione zinc shampoo 
Malin and Goetz 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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Dandruff Shampoo

Active ingredient              Purpose

Pyrithizone Zinc 1.9%      Anti-Dandruff

Uses Controls the symptoms of:

  • dandruff 
  • seborrheic dermatitis

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

Stop use and ask a doctor if

too much skin irritation or sensitivity develops and increases

Warnings

For external use only

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water

Directions

  • for best results, use at least twice a week or as directed by a doctor
  • Wet hair thoroughly, pour into palm; rub hands together to form a rich lather and massage into scalp
  • Rinse thoroughly
  • repeat if desired

Water (aqua), Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Sodium Laureth Sulfate, Acrylates/C1-30 Alkyl Acrylate Crosspolymer, Sodium Benzoate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Potassium Sorbate, Sodium Hydroxide, Glycerin, Disodium EDTA, Eucalyptus Globulus Leaf Extract, Limonene, Panthenol, Betaine, Hydrolyzed Wheat Starch, Serine, Glutamic Acid, Glycine, Lysine, Alanine, Arginine, Threonine

(Malin+Goetz)

Dandruff Shampoo

8fl.oz. 236ml

Bottle

DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53634-127
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TEA TREE OIL (UNII: VIF565UC2G)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
PANTHENOL (UNII: WV9CM0O67Z)  
BETAINE (UNII: 3SCV180C9W)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
SORBITOL (UNII: 506T60A25R)  
PROLINE (UNII: 9DLQ4CIU6V)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
SERINE (UNII: 452VLY9402)  
GLUTAMIC ACID (UNII: 3KX376GY7L)  
GLYCINE (UNII: TE7660XO1C)  
LYSINE (UNII: K3Z4F929H6)  
ALANINE (UNII: OF5P57N2ZX)  
ARGININE (UNII: 94ZLA3W45F)  
THREONINE (UNII: 2ZD004190S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53634-127-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product12/04/201703/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H12/04/201703/21/2023
Labeler - Malin and Goetz Inc (138615930)
Establishment
NameAddressID/FEIBusiness Operations
Milbar Laboratories, Inc.195556790manufacture(53634-127)

Revised: 6/2023
 
Malin and Goetz Inc