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Baby XtraCare Oatmeal by Rejoice International

Dosage form: lotion
Ingredients: DIMETHICONE 1.2g in 100g
Labeler: Rejoice International
NDC Code: 57337-070

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.

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  Store at room temperature.

Questions/Comments? 1-855-345-5575

DISTRIBUTED BY

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 U.S.A.

MADE IN CHINA

BABY XTRACARE OATMEAL 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-070
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE1.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
PETROLATUM 
MINERAL OIL 
GLYCERIN 
GLYCERYL MONOSTEARATE 
PROPYLENE GLYCOL 
PEG-100 STEARATE 
POLYACRYLAMIDE (10000 MW) 
CETYL ALCOHOL 
AVENA SATIVA WHOLE 
DMDM HYDANTOIN 
STEARYL ALCOHOL 
C13-14 ISOPARAFFIN 
LAURETH-7 
EDETATE DISODIUM 
ALOE VERA LEAF 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:57337-070-01227 g in 1 BOTTLE
2NDC:57337-070-02354 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/16/2015
Labeler - Rejoice International (078741245)
Establishment
NameAddressID/FEIOperations
China Ningbo Shangge Cosmetic Technology Corp529287434manufacture(57337-070)

Revised: 02/2015
 
Rejoice International

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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