PERSONAL CARE DRY SCALP- pyrithione zinc shampoo

Personal CARE by

Drug Labeling and Warnings

Personal CARE by is a Otc medication manufactured, distributed, or labeled by Delta Brands & Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Use

helps to treat flakes, itch, irritation, oilness or dryness caused by dandruff.

Warnings

For external use only

When using this product

■ avoid contact with eyes ■ if contact occurs, rinse eyes with plenty of water.

Stop use and ask a doctor if

■ if condition does not improve or worsen after regular use of this product as directed

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center immediately.

Directions

■ wet hair ■ squeeze small amount into palm ■ lather ■ rinse well ■ for best results use at least twice a week or as directed by a doctor

Inactive ingredients

water (aqua), sodium laureth sulfate sodium lauryl sulfate, cocamide MEA,sodium chloride, dimethicone, cetyl alcohol, polyquaternium-10, glycol distearate, disodium EDTA, cocamidopropyl betaine, DMDM hydantoin, citric acid, fragrance, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone,FD&C Blue No. 1

Package Label

INGREDIENTS AND APPEARANCE

PERSONAL CARE  DRY SCALP
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72133-047
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 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
BENZYL ALCOHOL (UNII: LKG8494WBH)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72133-047-13	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/09/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	04/09/2018

Labeler - Delta Brands & Products LLC (080999173)