Active Ingredient.

PYRITHIONE ZINC (1%)

Purpose

Anti dandruff

Uses

To prevent recurrence of flaking and itching associated with dandruff.

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.

Keep out of reach of children.

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

Directions

For best resuts, use at least twice a week or as directed by a doctor.
For maximum dandruff control, use every time you shampoo.
Wet hair, massage onto scalp and rinse. Repeat if desired.

Other Information

Store at room temperature

Inactive Ingredients

Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Acrylates Copolymer, Glycol Distearate, Cocamidopropyl Betaine, Laureth-4, Dimethicone, Fragrance (Parfum), Cocamide MEA, Guar Hydroxypropyltrmonium Chloride, Sodium Hydroxide, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (Cl 42090), Red 33 (Cl 17200).

Principal Display Panel

PP04

2 IN 1
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71141-027
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
LAURETH-4 (UNII: 6HQ855798J)
EDETATE SODIUM (UNII: MP1J8420LU)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71141-027-04	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/12/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	08/12/2021

Labeler - LIDL US LLC (079389709)

Registrant - Apollo Health and Beauty Care (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care		201901209	manufacture(71141-027)

71141-027, LIDL US LLC