CERAVE ANTI DANDRUFF HYDRATING- pyrithione zinc shampoo

CeraVe Anti Dandruff Hydrating by

Drug Labeling and Warnings

CeraVe Anti Dandruff Hydrating by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA Products, Inc., L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Use

helps 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

conditions worsens or does not improve after regular use of this product as directed

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
• wet hair and massage onto scalp
• rinse and repeat if desired

Inactive ingredients

water, sodium C14-16 olefin sulfonate, disodium laureth sulfosuccinate, disodium cocoamphodiacetate, sodium chloride, glycol distearate, amodimethicone, sodium lauryl sulfoacetate, PPG-5-ceteth-20, potato starch modified, cocamide MIPA, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, trideceth-6, triethyl citrate, sodium hydroxide, sodium benzoate, sodium lauroyl lactylate, salicylic acid, sodium polynaphthalenesulfonate, sodium hyaluronate, cholesterol, phenoxyethanol, coco-betaine, propylene glycol, citric acid, cetrimonium chloride, caprylyl glycol, xanthan gum, phytosphingosine, polyquaternium-10, acrylates copolymer, benzoic acid

Questions or Comments?

Toll-free number 1-888-768-2915

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE ANTI DANDRUFF HYDRATING 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-298
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)
SODIUM C14 OLEFIN SULFONATE (UNII: N816E2SOKI)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
AMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
SODIUM HYDROLYZED POTATO STARCH DODECENYLSUCCINATE (UNII: APY6XCX4XA)
COCAMIDE MIPA (UNII: 21X4Y0VTB1)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CARBOMER (UNII: 0A5MM307FC)
NIACINAMIDE (UNII: 25X51I8RD4)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCO-BETAINE (UNII: 03DH2IZ3FY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID (UNII: 2968PHW8QP)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
3-PHYTASE A (ASPERGILLIS NIGER) (UNII: D87X4XYB87)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
ACRYLAMIDOPROPYLTRIMONIUM CHLORIDE/ACRYLAMIDE COPOLYMER (400 MPA.S) (UNII: 2RX4MI2LCX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-298-01	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/11/2024
2	NDC: 49967-298-02	29 mL in 1 PACKET; Type 0: Not a Combination Product	01/11/2024
3	NDC: 49967-298-03	30 mL in 1 TUBE; Type 0: Not a Combination Product	01/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	01/11/2024

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products, Inc.		624244349	manufacture(49967-298)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		960317444	manufacture(49967-298)