FLAKES CEDAR MINT ANTI DANDRUFF- pyrithione zinc lotion/shampoo 
Cosco International, Inc.

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Flakes Cedar Mint Anti Dandruff Shampoo

DRUG FACTS

Active Ingredients:                  Purpose:

Pyrithione Zinc 2%..................Anti dandruff

Use:  For the control of the symptoms of dandruff and or seborrheic dermatitis

Warnings

for external use only

Keep out of reach of children.  

If swallowed, get medical help or contact a Poison Control Center immediately.

When using this product avoid contact with 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.

Directions: for best results, use at least twice a week or as directed by a doctor.
• Wet hair thoroughly
• Massage a liberal amount into your scalp
• Leave lather on scalp for several minutes
• Rinse and repeat.

Inactive Ingredients:
WATER, SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL BETAINE, COCO MONOETHANOLAMIDE, FRAGRANCE, GLYCERIN, PHENOXYETHANOL, PEPPERMINT OIL, HYDROXYPROPYL GUAR, HYDROXYPROPYL TRIMONIUM CHLORIDE, CAPRYLYL GLYCOL, POLYACRYLATE CROSSPOLYMER-6, METHYL DIISOPROPYL PROPIONAMIDE, TEA TREE OIL, CITRIC ACID

Questions?

help@byeflakes.com

Other Information
Store at room temperature between 68-77°F (20-25°C).
Do not expose to excessive heat

266ml label

85ml label

FLAKES CEDAR MINT ANTI DANDRUFF 
pyrithione zinc lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-1400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.02 kg  in 1 kg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GUARAPROLOSE (1300 MPA.S AT 1%) (UNII: 1530WMS90S)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
TEA TREE OIL (UNII: VIF565UC2G)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52261-1400-10.266 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2022
2NDC:52261-1400-20.085 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM03212/01/2022
Labeler - Cosco International, Inc. (016433141)
Registrant - Cosco International, Inc. (016433141)
Establishment
NameAddressID/FEIBusiness Operations
Cosco International, Inc.016433141manufacture(52261-1400) , label(52261-1400) , pack(52261-1400)

Revised: 5/2024
Document Id: 274fbb67-41af-4c33-ad46-0ad36a2cc14a
Set id: 8575e7a0-4290-40a0-949c-317951b440b8
Version: 2
Effective Time: 20240521
 
Cosco International, Inc.