FLAKES CEDAR MINT ANTI DANDRUFF- pyrithione zinc lotion/shampoo

Flakes Cedar Mint Anti Dandruff by

Drug Labeling and Warnings

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

Drug Details [pdf]

DRUG FACTS

Active Ingredients:                  Purpose:

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

PURPOSE

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

WARNINGS

Warnings

for external use only

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  

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

WHEN USING

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

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

Questions?

help@byeflakes.com

STORAGE AND HANDLING

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLAKES CEDAR MINT ANTI DANDRUFF 
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52261-1400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.02 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52261-1400-1	0.266 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2022
2	NDC: 52261-1400-2	0.085 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	12/01/2022

Labeler - Cosco International, Inc. (016433141)

Registrant - Cosco International, Inc. (016433141)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc.		016433141	manufacture(52261-1400) , label(52261-1400) , pack(52261-1400)