DANDRUFF- pyrithione zinc shampoo

Dandruff by

Drug Labeling and Warnings

Dandruff by is a Otc medication manufactured, distributed, or labeled by Malin and Goetz Inc, Milbar Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient              Purpose

Pyrithizone Zinc 1.9%      Anti-Dandruff

PURPOSE

Uses Controls the symptoms of:

• dandruff 
• seborrheic dermatitis

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if

too much skin irritation or sensitivity develops and increases

WARNINGS

Warnings

For external use only

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

(Malin+Goetz)

Dandruff Shampoo

8fl.oz. 236ml

INGREDIENTS AND APPEARANCE

DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53634-127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53634-127-01	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	12/04/2017

Labeler - Malin and Goetz Inc (138615930)

Establishment
Name	Address	ID/FEI	Business Operations
Milbar Laboratories, Inc.		195556790	manufacture(53634-127)