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XtraCare with cooling action Oatmeal Skin Relief Calmin

Medically reviewed on February 7, 2018

Dosage form: lotion
Ingredients: DIMETHICONE 3g in 227g
Labeler: Rejoice International
NDC Code: 57337-055

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 1/3% ......... Skin Protectant

XtraCare (with cooling action) Oatmeal Skin Relief Calming Lotion

dimethicone skin protectant

with natural colloidal oatmeal

provides immediate and lasting moisture relief for itchy, extra dry skin

12 fl oz (354 mL)

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.

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.

Directions  apply liberally as often as needed.

Other Information  store at room temperature.

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC.

48325 BINGHAMPTON DR.,

NORTHVILLE, MI 48168 USA

MADE IN CHINA

Inactive Ingredients

water, paraffinum liquidum, isopropyl myristate, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, menthol, aloe barbadensis leaf juice, methylparaben, propylparaben.

XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-055
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE3 g  in 227 g
Inactive Ingredients
Ingredient NameStrength
WATER 
MINERAL OIL 
PETROLATUM 
GLYCERIN 
GLYCERYL MONOSTEARATE 
PROPYLENE GLYCOL 
PEG-100 STEARATE 
POLYACRYLAMIDE (1500 MW) 
CETYL ALCOHOL 
OAT 
DMDM HYDANTOIN 
STEARYL ALCOHOL 
C13-14 ISOPARAFFIN 
LAURETH-7 
EDETATE DISODIUM 
MENTHOL 
ALOE VERA LEAF 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:57337-055-01227 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/26/2013
Labeler - Rejoice International (078741245)
Establishment
NameAddressID/FEIOperations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(57337-055)

 
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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