Label: BEING WELL BODY DAILY MOISTURIZING- dimethicone lotion

  • 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 February 18, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient
    Dimethicone 1.25%

  • PURPOSE

    Purpose
    Skin protectant

  • INDICATIONS & USAGE

    Uses

    ■Helps prevent and temporarily protects chafed, chapped, or cracked skin

    ■Helps prevent and protect from the drying effects of wind and cold weather

  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product

    ■Do not get into eyes

  • STOP USE

    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.

  • DO NOT USE

    Do not use on

    ■Deep or puncture wounds

    ■Animal bites

    ■Serious burns

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions Apply as needed

  • INACTIVE INGREDIENT

    Inactive ingredients avena sativa (oat) kernel flour, benzyl alcohol, ceteareth-20, cetrimonium chloride, cetyl alcohol, FD&C blue no.1, FD&C yellow no.5, FD&C yellow no.6, glycerin, isopropyl palmitate, methylchloroisothiazolinone, methylisothiazolinone, petrolatum, triethanolamine, water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BEING WELL BODY  DAILY MOISTURIZING
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46994-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46994-500-12355 mL in 1 BOTTLE, PLASTIC
    2NDC:46994-500-18532 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2013
    Labeler - Save-A-Lot Food Stores Ltd (095484572)
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