CERAVE DEVELOPED WITH DERMATOLOGIST BABY ECZEMA RELIEF CREAM- oatmeal cream

CeraVe Developed With Dermatologist Baby Eczema Relief Cream by

Drug Labeling and Warnings

CeraVe Developed With Dermatologist Baby Eczema Relief Cream 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, butyrospermum parkii (shea) butter, glycerin, dimethicone, cetearyl alcohol, niacinamide, caprylic/capric triglyceride, glyceryl stearate, PEG-100 stearate, ammonium polyacryloyldimethyl taurate, ceramide np, ceramide ap, ceramide eop, sorbitan tristearate, carbomer, cetearyl isononanoate, behentrimonium methosulfate, triethyl citrate, sodium benzoate, sodium lauroyl lactylate, sodium hyaluronate, cholesterol, phenoxyethanol, tocopherol, citric acid, caprylyl glycol, trisodium ethylenediamine disuccinate, xanthan gum, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phytosphingosine, octyldodecanol, benzoic acid, PEG-20 methyl glucose sesquistearate

Questions or comments?

Toll-free number 1-888-768-2915

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE DEVELOPED WITH DERMATOLOGIST BABY ECZEMA RELIEF CREAM 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-536
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)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
NIACINAMIDE (UNII: 25X51I8RD4)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: F01RIY4371)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
CARBOMER (UNII: 0A5MM307FC)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRIC ACID (UNII: 2968PHW8QP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
XANTHAN GUM (UNII: TTV12P4NEE)
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE (UNII: 255PIF62MS)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
OCTYLDODECANOL (UNII: 461N1O614Y)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-536-01	148 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2025
2	NDC: 49967-536-02	5 mL in 1 TUBE; Type 0: Not a Combination Product	05/15/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	01/01/2025

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC.		624244349	manufacture(49967-536)