NURTURE SKIN PROTECTANT (DIMETHICONE) CREAM [RISE GLOBAL PRODUCTS]

NURTURE SKIN PROTECTANT (DIMETHICONE) CREAM [RISE GLOBAL PRODUCTS]
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NDC 59973-002-01
Set ID 1d1d68e6-46e1-40a1-9663-04ccdcb6da05
Category HUMAN OTC DRUG LABEL
Packager Rise Global Products
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Active Ingredient                        Purpose

    Dimethicone 1.0%..............Skin Protectant

  • PURPOSE

    Long-lasting nourishing formula that helps prevent dry, cracked skin.

    • Non-Sensitizing
    • Non-Allergenic
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • INDICATIONS & USAGE

    Uses

    Temporarily protects and helps relieve chapped or cracked skin. 

    Beneficial for face, hands, body and legs

  • WARNINGS

    Warnings

    For External Use Only

    Do Not Use

    • on deep or puncture wounds
    • on animal bites
    • on serious burns

    When using this product

    • Do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last for more than 7 days or clear up and occur again within a few days
  • DOSAGE & ADMINISTRATION

    Directions

    • Cleanse skin with Nurture(TM) Foaming Body Cleanser
    • Apply cream liberally to affected area as needed
  • OTHER SAFETY INFORMATION

    Other Information

    • Protect from freezing
    • Avoid excessive heat
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, canola oil, alow barbadensis leaf juice, PEG-8, glyceryl stearate, glycerin, propylene glycol, cyclomethicone, cetyl alcohol, stearic acid, triethanolamine, PEG-100 Stearate, allantoin, pyridoxine HCL, niacinamide, glycine, L-taurine, N-acetyl-L-cysteine, methylsulfonylmethane, L-proline, vanillin, citrus aurantium dulcis (orange) peel oil, citrus tangerina (tangerine) peel oil, citrus grandis (grapefruit) peel oil, dimethicone/vinyl dimethicone crosspolymer, citric acid, urea, polymethylsilsesquioxane, ammonium acryloyldimethyl taurate/vp copolymer, phenoxyethanol, DMDM hydantoin.

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    NURTURE SKIN PROTECTANT 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59973-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    SESAME OIL (UNII: QX10HYY4QV)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    MANDARIN OIL (UNII: NJO720F72R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCINE (UNII: TE7660XO1C)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    TAURINE (UNII: 1EQV5MLY3D)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VANILLIN (UNII: CHI530446X)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59973-002-01118 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2012
    Labeler - Rise Global Products (078587681)
    Establishment
    NameAddressID/FEIBusiness Operations
    Omega Packaging361281991manufacture(59973-002)

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