PYRITHIONE ZINC by BRANDS INTERNATIONAL PYRITHIONE ZINC shampoo

PYRITHIONE ZINC by

Drug Labeling and Warnings

PYRITHIONE ZINC by is a Otc medication manufactured, distributed, or labeled by BRANDS INTERNATIONAL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

For maximum dandruff control, use every time you shampoo.
Wet hair, massage unto scalp, rinse, and repeat if desired.

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

WARNINGS

For external use only.

INACTIVE INGREDIENT

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glycol Distearate, Aloe vera Leaf Extract, Parfum, Vitamin E, Methylchloroisothiazolinone,Methylisothiazolinone, FD&C Blue#1 ,FD&C Red#33.

INDICATIONS & USAGE

Helps prevent recurrence of flaking and itching associated with dandruff.

KEEP OUT OF REACH OF CHILDREN

Keep Out of children’s reach.

PURPOSE

Anti-dandruff

ACTIVE INGREDIENT

Pyrithione Zinc 0.3%

STOP USE

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

WHEN USING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PYRITHIONE ZINC 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50157-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
EDETATE SODIUM (UNII: MP1J8420LU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BASIC BLUE 1 (UNII: 92N74OA24D)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50157-125-10	295 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/16/2022
2	NDC: 50157-125-35	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/16/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M032	08/16/2022

Labeler - BRANDS INTERNATIONAL (243748238)

Establishment
Name	Address	ID/FEI	Business Operations
BRANDS INTERNATIONAL		243748238	manufacture(50157-125)