BABY XTRACARE OATMEAL- dimethicone lotion 
China Ningbo Shangge Cosmetic Technology Corp

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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Baby XtraCare Oatmeal

Active Ingredient                                      Purpose

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

Use

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

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

Baby XtraCare®

Oatmeal Daily Moisturizing Lotion

Lightly Scented

Dimethicon Skin Protectant with Natural Oat Extract

Helps Soothe & Soften Baby's Skin

12 FL OZ (354 mL)

Directions

Apply liberally as often as needed.

Warnings

For extenal 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 7days or clear up and occur again within a few days.

Inactive Ingredients

water, petrolatum, mineral oil, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa (oatmeal) kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, aloe barbadensis leaf juice, methylparaben, propylparaben.

Other Information  S tore at room temperature.

Questions/Comments? 1-855-345-5575

DISTRIBUTED BY

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 U.S.A.

MADE IN CHINA

8oz label image

12oz label image

BABY XTRACARE OATMEAL 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58503-070-01227 g in 1 BOTTLE; Type 0: Not a Combination Product02/16/2015
2NDC:58503-070-02354 g in 1 BOTTLE; Type 0: Not a Combination Product02/16/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/16/2015
Labeler - China Ningbo Shangge Cosmetic Technology Corp (529287434)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp529287434manufacture(58503-070)

Revised: 9/2019
Document Id: 9270a4e0-f5cc-0731-e053-2995a90a818b
Set id: cb357bc3-f7f4-406d-b124-45f8f7377bb6
Version: 2
Effective Time: 20190913
 
China Ningbo Shangge Cosmetic Technology Corp