XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN- 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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XtraCare with cooling action Oatmeal Skin Relief Calmin

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.

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XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5 mg  in 354 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
OAT (UNII: Z6J799EAJK)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MENTHOL (UNII: L7T10EIP3A)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58503-038-01354 mg in 1 BOTTLE; Type 0: Not a Combination Product11/26/2013
2NDC:58503-038-02227 mg in 1 BOTTLE; Type 0: Not a Combination Product11/26/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/26/2013
Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-038)

Revised: 9/2019
Document Id: 92627465-d2c0-aee0-e053-2995a90afba7
Set id: 4452b70f-03b9-48a1-8b81-b30f39aea469
Version: 3
Effective Time: 20190912
 
China Ningbo Shangge Cosmetic Technology Corp.