CERAVE DEVELOPED WITH DERMATOLOGISTS ECZEMA RELIEF CREAMY- oatmeal oil

CeraVe Developed with Dermatologists Eczema Relief Creamy by

Drug Labeling and Warnings

CeraVe Developed with Dermatologists Eczema Relief Creamy by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'OREAL USA PRODUCTS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Colloidal oatmeal 1%

Purpose

Skin protectant

Uses

• temporarily protects and helps relieve minor skin irritation and itching due to: eczema rashes

Warnings

For external use only

When using this product

do not get into eyes

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

apply as needed

Inactive ingredients

water, cetearyl alcohol, glycerin, cetyl alcohol, ceteareth-20, olea europaea (olive) fruit oil, isononyl isononanoate, carthamus tinctorius (safflower) seed oil, PEG-100 stearate, potassium phosphate, allantoin, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, glyceryl stearate. glycine soja (soybean) oil, behentrimonium methosulfate, vitis vinifera (grape) seed oil, sodium PCA, ophiopogon japonicus root extract, sodium lauroyl lactylate, helianthus annuus (sunflower) seed oil, cholesterol, rosmarinus officinalis (rosemary) extract, rosmarinus officinalis (rosemary) leaf extract, phenoxyethanol, chlorphenesin, dipotassium phosphate, tocopherol, propylheptyl caprylate, hydroxyacetophenone, hydrolyzed hyaluronic acid, persea gratissima (avocado) oil, xanthan gum, phytosphingosine, ethylhexylglycerin

Questions or comments?

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PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE DEVELOPED WITH DERMATOLOGISTS ECZEMA RELIEF CREAMY 
oatmeal oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-951
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
OLIVE OIL (UNII: 6UYK2W1W1E)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
SAFFLOWER OIL (UNII: 65UEH262IS)
PEG-100 STEARATE (UNII: YD01N1999R)
MONOBASIC POTASSIUM PHOSPHATE (UNII: 4J9FJ0HL51)
ALLANTOIN (UNII: 344S277G0Z)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SOYBEAN OIL (UNII: 241ATL177A)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
GRAPE SEED OIL (UNII: 930MLC8XGG)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ROSEMARY (UNII: IJ67X351P9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)
TOCOPHEROL (UNII: R0ZB2556P8)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
HYALURONIC ACID (UNII: S270N0TRQY)
AVOCADO OIL (UNII: 6VNO72PFC1)
XANTHAN GUM (UNII: TTV12P4NEE)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-951-01	236 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2020
2	NDC: 49967-951-02	100 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	12/01/2020

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC.		624244349	manufacture(49967-951)