XTRACARE OATMEAL DAILY MOISTURIZING 8 OZ- 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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XtraCare Oatmeal Daily Moisturizing Lotion Tube 8 oz

Active ingredient

Dimethicone 1.3%

Purpose

Skin Protectant

Uses

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

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 immediately.

Directions apply liberally as often as needed.

Other information Store at room temperature.

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

Questions/comments? 1-855-345-5575

Tube Label

XTRACARE OATMEAL DAILY MOISTURIZING  8 OZ
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-139
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
PETROLATUM (UNII: 4T6H12BN9U)  
OAT (UNII: Z6J799EAJK)  
PEG-100 STEARATE (UNII: YD01N1999R)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
LAURETH-7 (UNII: Z95S6G8201)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57337-139-01227 g in 1 TUBE; Type 0: Not a Combination Product04/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/19/2021
Labeler - Rejoice International Inc. (078741245)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Technology Co., Ltd.529287434manufacture(57337-139)

Revised: 4/2021
Document Id: c0670b60-46f2-9d9d-e053-2995a90a8c19
Set id: c0670819-830e-4082-e053-2a95a90adadc
Version: 1
Effective Time: 20210420
 
Rejoice International Inc.