OATMEAL SKIN RELIEF CALMING . 8OZ- dimethicone lotion 
Rejoice International 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

Dimethicone 1.3%

Purpose

Skin protectant

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

Use

Help prevent and temporarily protects chafed, chapped, or cracked skin.

Warnings For external use only.

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

Do not use on

Deep or puncture wounds
Animal bites
Serious burns

Stop use and ask a doctor if conditions worsens. Symptoms last more than 7 days or clear up and occur again within a few days.

Directions apply liberally as often as needed.

Other Information store at room temperature.

Inactive Ingredients

Water, Petrolatum, Cetyl Alcohol, Glyceryl Stearate, Propylene Glycol, Glycerin, Stearyl Alcohol, PEG-100 Stearate, Polyacrylamide, DMDM Hydrantoin, Isopropyl Myristate, Fragrance, C13-14 Isoparaffin, Laureth-7, Avena Sativa (Oat) Kernel Extract, Disodium EDTA, Methylparaben, Propylparaben

label

OATMEAL SKIN RELIEF CALMING .  8OZ
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-100
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
CETYL ALCOHOL (UNII: 936JST6JCN)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LAURETH-7 (UNII: Z95S6G8201)  
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CETYL STEARATE (UNII: 06RI5UQA7L)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57337-100-01227 g in 1 BOTTLE; Type 0: Not a Combination Product03/07/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/07/2019
Labeler - Rejoice International Inc. (078741245)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(57337-100)

Revised: 3/2019
Document Id: 8384b028-7b9c-2a7b-e053-2a91aa0a342c
Set id: 8384dc52-ba36-da3d-e053-2a91aa0a4f40
Version: 1
Effective Time: 20190307
 
Rejoice International Inc.