XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]

XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]
PDF | XML

NDC 57337-055-01
Set ID 29abd476-c32d-49f0-b283-30f4ba570ab4
Category HUMAN OTC DRUG LABEL
Packager Rejoice International
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Active Ingredient                     Purpose

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

  • PURPOSE

    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

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

  • INDICATIONS & USAGE

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

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    Directions  apply liberally as often as needed.

  • OTHER SAFETY INFORMATION

    Other Information  store at room temperature.

    DISTRIBUTED BY:

    REJOICE INTERNATIONAL INC.

    48325 BINGHAMPTON DR.,

    NORTHVILLE, MI 48168 USA

    MADE IN CHINA

  • INACTIVE INGREDIENT

    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.

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE3 g  in 227 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    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:57337-055-01227 g 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 - Rejoice International (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(57337-055)

Related Drugs