Label: NURTURE BARRIER- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated August 16, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient                        Purpose

    Dimethicone 5%................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 BARRIER 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59973-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    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)  
    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)  
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
    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)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59973-001-01118 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(59973-001)
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