LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE LIPIKAR ECZEMA SOOTHING RELIEF- oatmeal cream

La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, COSMETIQUE ACTIVE PRODUCTION. 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, shea butter, glycerin, dimethicone, mineral oil, niacinamide, cetearyl alcohol, rapeseed seed oil, ammonium polyacryloyldimethyl taurate, PEG-100 stearate, glyceryl stearate, tocopherol, sodium benzoate, PEG-20 methyl glucose sesquistearate, dimethiconol, mannose, xanthan gum, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, capryloyl glycine, microcrystalline wax, sorbitan tristearate, paraffin, discodium EDTA, vitreoscilla ferment, citric acid

Questions or comments?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE LIPIKAR ECZEMA SOOTHING RELIEF 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-621
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)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
MINERAL OIL (UNII: T5L8T28FGP)
NIACINAMIDE (UNII: 25X51I8RD4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CANOLA OIL (UNII: 331KBJ17RK)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
MANNOSE, D- (UNII: PHA4727WTP)
XANTHAN GUM (UNII: TTV12P4NEE)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
PARAFFIN (UNII: I9O0E3H2ZE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-621-01	1 in 1 CARTON	11/21/2017
1		5 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-621-02	200 mL in 1 TUBE; Type 0: Not a Combination Product	11/21/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/21/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-621) , pack(49967-621)

Establishment
Name	Address	ID/FEI	Business Operations
BPS		272259304	pack(49967-621)