ION 2 IN 1 ANTI-DANDRUFF ANTI-DANDRUFF- pyrithione zinc shampoo

ion 2 in 1 anti-dandruff by

Drug Labeling and Warnings

ion 2 in 1 anti-dandruff by is a Otc medication manufactured, distributed, or labeled by Arcadia Beauty Labs LLC, Garcoa, Inc., Sigan Industries INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Pyrithione Zinc 1%

Purpose

Anti-dandruff

Use

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

For external use only

When using this product

• avoid contact with the 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 (1-800-222-1222) right away

Directions

• shake well
• wet hair
• massage onto scalp
• rinse
• repeat if desired
• for best results use at least twice a week or as directed by a doctor
• for maximum dandruff control, use every time you shampoo

Other information

store at room temperature

Inactive ingredients

Water (Aqua, Eau), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DIPA, Sodium Chloride, Glycerin, Phenoxyethanol, Fragrance (Parfum), Acrylates/Steareth-20 Methacrylate Copolymer, Polyquaternium-7, Butyrospermum Parkii (Shea) Butter, Dimethicone, Butylene Glycol, Chlorphenesin, Guar Hydroxypropyltrimonium Chloride, Styrene/VP Copolymer, Panthenol, Tetrasodium EDTA, Punica Granatum Peel Extract, Red 33 (CI 17200), Citric Acid, Aloe Barbadensis Leaf Extract, Red 4 (CI 14700), Benzyl Benzoate, Limonene, Linalool, Hexyl Cinnamal.

Questions or comments?

1-888-763-1824

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Distributed by Arcadia Beauty Labs LLC,
9975 Moya Boulevard, Reno, Nevada 89506

PRINCIPAL DISPLAY PANEL - 310 mL Bottle Carton

dandruff
solutions

WITH
POMEGRANATE
& 1% PYRITHIONE
ZINC
SAFE FOR
COLOR TREATED
HAIR

ion®

2-in-1
anti-dandruff
shampoo +
conditioner

SHAMPOOING
REVITALISANT
ANTIPELLICULES

CRUELTY FREE*

10.5 fl. oz. (310 mL)

ANTI-DANDRUFF

INGREDIENTS AND APPEARANCE

ION 2 IN 1 ANTI-DANDRUFF   ANTI-DANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71990-712
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q)
Sodium Chloride (UNII: 451W47IQ8X)
Glycerin (UNII: PDC6A3C0OX)
Phenoxyethanol (UNII: HIE492ZZ3T)
ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
SHEA BUTTER (UNII: K49155WL9Y)
Dimethicone (UNII: 92RU3N3Y1O)
Butylene Glycol (UNII: 3XUS85K0RA)
Chlorphenesin (UNII: I670DAL4SZ)
Guar Hydroxypropyltrimonium Chloride (UNII: B16G315W7A)
Panthenol (UNII: WV9CM0O67Z)
EDETATE SODIUM (UNII: MP1J8420LU)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
Benzyl Benzoate (UNII: N863NB338G)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71990-712-01	310 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M032	03/25/2024

Labeler - Arcadia Beauty Labs LLC (078445217)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC		255106239	MANUFACTURE(71990-712) , LABEL(71990-712) , PACK(71990-712)