FLAKES ANTI DANDRUFF HAIR AND SCALP SERUM- pyrithione zinc liquid

Flakes Anti Dandruff Hair and Scalp Serum by

Drug Labeling and Warnings

Flakes Anti Dandruff Hair and Scalp Serum by is a Otc medication manufactured, distributed, or labeled by Cosco International Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Pyrithione Zinc – 0.25%

Purpose:

Anti dandruff

Uses:

For the relief of dandruff and seborrheic dermatitis. Controls scalp flaking associated with dandruff. Helps reduce scalp dryness and relieve itching, irritation, and redness asscoiated with 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

Ask a doctor before use before using this product

When using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation develops, condition worsens, or does not improve after regular use of this product as directed.

Inactive ingredients:

Water, Glycerin, Cetostearyl Alcohol, Behentrimonium, Methosulfate, Caprylic/Capric Triglyceride, Polyquaternium-10, Biotinoyl Tripeptide-1, Copper Tripeptide-1, Piroctone Olamine, Sodium Hyaluronate, Saw Palmetto Extract, Hydroxypropyltrimonium Honey, Panthenol, Niacinamide, Hydrolyzed Keratin, Salicylic Acid, Caffeine, Ashwagandha Oil, Biotin, Tea Tree Oil, Propylene Glycol, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Trehalose

Active Ingredient:

Pyrithione Zinc-0.25% (Anti-dandruff)

Questions?

help@byeflakes.com  Call:917-581-4875

OTHER SAFETY INFORMATION

Directions

For the best results, apply to the affected areas one to four times daily or as directed by a doctor. Spread over the whole scalp, or only on areas affected by dandruff. Massage it gently. Leave it on the scalp until completely absorbed. 

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLAKES ANTI DANDRUFF HAIR AND SCALP SERUM 
pyrithione zinc liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52261-1401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.0025 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
Behentrimonium Methosulfate (UNII: 5SHP745C61)
Cetearyl Alcohol (UNII: 2DMT128M1S)
Biotinoyl Tripeptide-1 (UNII: O6380721VA)
Copper Tripeptide-1 (UNII: 6BJQ43T1I9)
Caprylic/Capric Triglyceride (UNII: C9H2L21V7U)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
Sodium Hyaluronate (UNII: YSE9PPT4TH)
SERENOA SERRULATA FRUIT POWDER (UNII: J7WWH9M8QS)
HONEY (UNII: Y9H1V576FH)
PANTHENOL (UNII: WV9CM0O67Z)
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)
NIACINAMIDE (UNII: 25X51I8RD4)
HAIR KERATIN AMINO ACIDS (UNII: G46579QK1M)
SALICYLIC ACID (UNII: O414PZ4LPZ)
CAFFEINE (UNII: 3G6A5W338E)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
BIOTIN (UNII: 6SO6U10H04)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TREHALOSE (UNII: B8WCK70T7I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52261-1401-1	1 in 1 CARTON	09/11/2025
1		0.055 kg in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	032	09/11/2025

Labeler - Cosco International Inc (016433141)

Registrant - Cosco International Inc (016433141)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International Inc		016433141	manufacture(52261-1401) , label(52261-1401) , pack(52261-1401)