LUCKY 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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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 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, FDC blue no. 1, fragrance, glycol distearate, laureth 10, methylchloroisothiazolinone, methylisothiazolinone,polyquarternium 7, sodium chloride, sodium laureth sulfate, styrene/acrylates copolymer, tetrasodium EDTA, triethanolamine, water, zinc sulfate

Package Label

image of package label

LUCKY  CLASSIC
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-045
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE) PYRITHIONE ZINC0.3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
COCAMIDOPROPYL BETAINE 
COCO DIETHANOLAMIDE 
COCO MONOETHANOLAMIDE 
COCO GLUCOSIDE 
FD&C BLUE NO. 1 
GLYCOL DISTEARATE 
LAURETH-10 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) 
SODIUM CHLORIDE 
SODIUM LAURETH SULFATE 
EDETATE SODIUM 
TROLAMINE 
WATER 
ZINC SULFATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:20276-045-12355 mL in 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/30/2012

Labeler - Delta Brands Inc (102672008)
Establishment
NameAddressID/FEIOperations
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil566220234manufacture

Revised: 06/2012 Delta Brands Inc