Lucky 2in1 Classic

Dosage form: shampoo
Ingredients: PYRITHIONE ZINC 0.3mL in 100mL
Labeler: Delta Brands Inc
NDC Code: 20276-046

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.

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 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

Package Label

LUCKY   2IN1 CLASSIC
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-046
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) 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-10 (400 CPS AT 2%) 
SODIUM CHLORIDE 
SODIUM LAURETH SULFATE 
EDETATE SODIUM 
TROLAMINE 
WATER 
ZINC SULFATE 
Packaging
#Item CodePackage Description
1NDC:20276-046-12355 mL in 1 BOTTLE, PLASTIC
2NDC:20276-046-14420 mL in 1 BOTTLE, PLASTIC
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(20276-046)

Revised: 07/2012
 
Delta Brands Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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