LUCKY 2IN1 CLASSIC- pyrithione zinc shampoo

Lucky by

Drug Labeling and Warnings

Lucky by is a Otc medication manufactured, distributed, or labeled by Delta Brands Inc, Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Pyrithione zinc 0.3%

Purpose

Anti-dandruff

Uses

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

Keep out of reach of children

Keep this and all drugs out of reach of children If swallowed get medical help or contact a Poison Control Center right away.

Directions

wet hair, squeeze small amount into palm lather, rinse well

Inactive ingredients

acrylates copolymer, benzyl alcohol, cocamidopropyl betaine, cocamide DEA, cocamide MEA, coco-glucoside, dimethicone, FD&C blue no. 1, fragrance, glycol distearate, laureth-10, methylchloroisothiazolinone, methylisothiazolinone, polyquaternium-10, sodium chloride, sodium laureth sulfate, styrene/acrylates coploymer,tetrasodium EDTA, triethanolamine, water, zinc acetate

Package Label

INGREDIENTS AND APPEARANCE

LUCKY  2IN1 CLASSIC
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20276-046
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 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
COCO GLUCOSIDE (UNII: ICS790225B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
LAURETH-10 (UNII: BD7AST04GA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
EDETATE SODIUM (UNII: MP1J8420LU)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
ZINC SULFATE (UNII: 89DS0H96TB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20276-046-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2012
2	NDC: 20276-046-14	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/30/2012

Labeler - Delta Brands Inc (102672008)

Establishment
Name	Address	ID/FEI	Business Operations
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil		566220234	manufacture(20276-046)