PYRITHIONE ZINC 0.5 DANDRUFF- pyrithione zinc shampoo

Pyrithione Zinc 0.5 Dandruff by

Drug Labeling and Warnings

Pyrithione Zinc 0.5 Dandruff by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient:

Pyrithione zinc 0.5% W/V

Purpose:

Anti-dandruff

Uses:

Helps prevent recurrence of flaking and itching associated with dandruff.

Directions:

Wet hair, massage onto scalp, rinse. Repeat if desired. For best results use at least twice a week or as directed by a doctor.

Other Information:

Store at 20°C to 25°C (68°F to 77°F)

Inactive Ingredients:

Water, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Cocamide Mea, Acrylated Co Polymer, Glycerin, Fragrance, Citric Acid, Disodium Edta, Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone, Guar Hydroxypropyltrimonium Chloride, Glycol Distearate, Menthol, Fd & C Blue No.1

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

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

ALL HAIR TYPES

Helps to relieve itching, dryness and flakes

Distributed by:
Universal Distribution Center LLC
96 Distribution Boulevard, Edison, NJ 08817
www.universaldc.com

Made in India                                                                           

Packaging

INGREDIENTS AND APPEARANCE

PYRITHIONE ZINC 0.5 DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-416
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (UNII: B16G315W7A)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-416-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	05/17/2024

Labeler - Universal Distribution Center LLC (019180459)