LOREAL PARIS EVER PURE DANDRUFF SCALP CARE AND DETOX- pyrithione zinc shampoo

LOreal Paris Ever Pure Dandruff Scalp Care and Detox by

Drug Labeling and Warnings

LOreal Paris Ever Pure Dandruff Scalp Care and Detox by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Pyrithone zinc 1%

Purpose

Antidandruff

Use

helpls prevent recurrence of scalp flaking and itching associated with dandruff

Warnings

For external use only

When using this product

avoid contact with the 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

Keep out of reach of children.

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

Directions

• for best results, use at least twice a week or as directed by a doctor
• apply to wet hair by gently massaging onto scalp and hair
• rinse well

Inactive ingredients

water, cocamidopropyl betaine, disodium laureth sulfosuccinate, sodium lauryl sulfoacetate, decyl glucoside, sodium lauroyl sarcosinate, glycol distearate, sodium chloride, coco-betaine, fragrance, amodimethicone, PPG-5-ceteth-20, acrylates copolymer, sodium benzoate, carbomer, PEG-55 propylene glycol oleate, propylene glycol, polyquaternium-39, menthol, hydrogenated starch hydrolysate, benzoic acid, trideceth-6, butylene glycol, citronellol, sodium polynaphthalenesulfonate, linalool, limonene, geraniol, cetrimonium chloride, citral, cellulose gum, tetrasodum EDTA, aphanizomenon flos-aquae extract, melia azadirachta leaf extract, methylisothiazolinone, phenoxyethanol, potassium sorbate

Questions or comments?

1-800-631-7358

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS EVER PURE DANDRUFF SCALP CARE AND DETOX 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-056
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO-BETAINE (UNII: 03DH2IZ3FY)
AMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOMER 940 (UNII: 4Q93RCW27E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: X2NH1K9F8K)
MENTHOL (UNII: L7T10EIP3A)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
BENZOIC ACID (UNII: 8SKN0B0MIM)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
GERANIOL (UNII: L837108USY)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
CITRAL (UNII: T7EU0O9VPP)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 150 MPA.S AT 1%) (UNII: 99H65D77XY)
EDETATE SODIUM (UNII: MP1J8420LU)
APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-056-01	250 mL in 1 TUBE; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	07/01/2020

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		960317444	manufacture(49967-056) , pack(49967-056)