Label: BEING WELL BODY DAILY MOISTURIZING- dimethicone lotion

  • NDC Code(s): 46994-500-12, 46994-500-18
  • Packager: Save-A-Lot Food Stores Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient
    Dimethicone 1.25%

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  • PURPOSE

    Purpose
    Skin protectant

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  • 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

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  • WARNINGS

    Warnings

    For external use only

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  • WHEN USING

    When using this product

    ■Do not get into eyes

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  • 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.

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  • DO NOT USE

    Do not use on

    ■Deep or puncture wounds

    ■Animal bites

    ■Serious burns

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • DOSAGE & ADMINISTRATION

    Directions Apply as needed

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  • 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

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  • INGREDIENTS AND APPEARANCE
    BEING WELL BODY  DAILY MOISTURIZING
    dimethicone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:46994-500
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 1.25 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    AVENA SATIVA FLOWERING TOP  
    BENZYL ALCOHOL  
    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  
    TROLAMINE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46994-500-12 355 mL in 1 BOTTLE, PLASTIC
    2 NDC:46994-500-18 532 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 03/01/2013
    Labeler - Save-A-Lot Food Stores Ltd (095484572)
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