OATMEAL DAILY MOISTURIZING 8OZ.- dimethicone lotion 
Davion, Inc.

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 daily moisturizing lotion (8 oz.)

Active Ingredient Purpose

Dimethicone 1.2% ......... Skin Protectant

Skin protectant

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

Warnings For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush with water.

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.

Do not use on

Directions apply liberally as often as needed.

Other Information store at room temperature.

DISTRIBUTED BY:

MIDWOOD BRANDS, INC.

10611 MONROE,

MATTHEWS, NC 28105 USA

MADE IN CHINA

Inactive Ingredients

Water, Petrolatum, Benzyl Alcohol, Glycerin, Isopropyl Palmitate, Avena Sativa (Oat) Kernel Extract, Steraryl Alcohol, Distearyldimonium Chloride, Sodium Chloride

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OATMEAL DAILY MOISTURIZING 8OZ. 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42669-099
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE3 g  in 227 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42669-099-01227 g in 1 BOTTLE; Type 0: Not a Combination Product10/10/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/10/2018
Labeler - Davion, Inc. (174542928)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(42669-099)

Revised: 10/2018
Document Id: 77e6e38a-1681-06f9-e053-2a91aa0a69c5
Set id: 77e6afc7-b9f9-3b32-e053-2991aa0ad57f
Version: 1
Effective Time: 20181010
 
Davion, Inc.