LUCKY 2IN1 CLASSIC- pyrithione zinc shampoo 
Delta Brands Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

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

image of package label

LUCKY  2IN1 CLASSIC
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-046
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.3 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20276-046-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/2012
2NDC:20276-046-14420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/30/2012
Labeler - Delta Brands Inc (102672008)
Establishment
NameAddressID/FEIBusiness Operations
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil566220234manufacture(20276-046)

Revised: 11/2019
Document Id: 98836374-7295-db9b-e053-2995a90a11e5
Set id: 6f0a19ce-b717-4ed7-ae41-3fc530b3f314
Version: 3
Effective Time: 20191129
 
Delta Brands Inc