LOREAL PARIS HAIR EXPERT EVER FRESH SULFATE FREE ANTIDANDRUFF- pyrithione zinc shampoo 
L'Oreal USA Products Inc

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.

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Drug Facts

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, benzoic acid, sorbitol, butylene glycol, trideceth-6, citronellol, sodium polynaphthalenesulfonate, linalool, limonene, geraniol, cetrimonium chloride, citral, cellulose gum, algae extract, melia azadirachta leaf extract, methylisothiazolinone, phenoxyethanol, potassium sorbate, sodium hydroxide, citric acid

Questions or comments?

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LOREAL PARIS HAIR EXPERT EVER FRESH SULFATE FREE ANTIDANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-343
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 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)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SORBITOL (UNII: 506T60A25R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
.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)  
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-343-01250 mL in 1 TUBE; Type 0: Not a Combination Product11/01/201603/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H11/01/201603/17/2023
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.960317444manufacture(49967-343)

Revised: 1/2023
 
L'Oreal USA Products Inc