OATMEAL- dimethicone lotion

OATMEAL by

Drug Labeling and Warnings

OATMEAL by is a Otc medication manufactured, distributed, or labeled by NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

oatmeal and cream

Oatmeal and Cream Lotion provides temporary relief for dry skin. It moisturize and prevents drying skin. Use daily for a naturally smooth and healthy looking skin. This naturally nourishing, non-greasy formula absorbs quickly and won't clog pores.

Active Ingredient

Dimethicone 1%

Purpose

Skin Protectant

Uses:

Helps prevent and protect from the drying effects of wind and cold weather.

Directions:

Apply daily or as needed

Warning:

For external use only. Do not use on deep puntured wounds, animal bites or serious burns.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

STOP USE

Stop use and ask doctor if conditions worsens. Symptons last more than 7 days or clear up and occur again.

Inactive Ingredients:

Water (Aqua), Mineral Oil, Getearyl Alcohol, Glycerin, Glyceryl Stearate, Petrolatum, Ceteareth-20, Propylene Glycol, Carbomer, Triethanolamine, Avena Stiva (OAT) Kernel Flour, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, DMDM Hydantoin, Dichlorobenzyl Alcohol, Iodopropynyl Butylcarbamate, FD&C Yellow No.5, FD&C Red No. 40.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OATMEAL 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76176-063
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
CETEARETH-22 (UNII: 28VZG1E234)
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)
MINERAL OIL (UNII: T5L8T28FGP)
CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H)
PETROLATUM (UNII: 4T6H12BN9U)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER 934 (UNII: Z135WT9208)
DICHLOROBENZYL ALCOHOL (UNII: 1NKX3648J9)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76176-063-01	354 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/01/2019

Labeler - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD (530766098)

Registrant - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD (530766098)

Establishment
Name	Address	ID/FEI	Business Operations
NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD		530766098	manufacture(76176-063)