OATMEAL- dimethicone lotion 
NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

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.

label

OATMEAL 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
CETEARETH-22 (UNII: 28VZG1E234)  
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)  
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
DICHLOROBENZYL ALCOHOL (UNII: 1NKX3648J9)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76176-063-01354 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/01/2019
Labeler - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD (530766098)
Registrant - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD (530766098)
Establishment
NameAddressID/FEIBusiness Operations
NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD530766098manufacture(76176-063)

Revised: 10/2022
Document Id: ebc33e4a-aff6-a326-e053-2a95a90a08c1
Set id: 8c1e84e9-6b93-8eff-e053-2a95a90a18b0
Version: 2
Effective Time: 20221024
 
NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD