DAILY MOISTURIZING (DIMETHICONE) LOTION [AMERICAN SALES CO]

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DAILY MOISTURIZING (DIMETHICONE) LOTION [AMERICAN SALES CO]
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NDC 41520-619-40
Set ID d0542550-36cd-4ac1-b640-414247d7c454
Category HUMAN OTC DRUG LABEL
Packager American Sales Co
Generic Name
Product Class
Product Number
Application Number PART347
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  • Claims

    Care One

    Oatmeal

    Hand + Body

    Daily Moisturizind Skin Protectant Lotion

  • active ingredient

    Dimethicone 1.3%

  • Purpose

    Skin protectant

  • Uses

    • helps prevent and temporarily protects chafed, chapped, cracked skin
    • helps protect from the drying effects of wind and cold weather
  • Warnings

    For external use only

  • Do not use

    • deep or puncture wounds
    • animal butes
    • serious burns
  • When using this product

    keep out of eyes

  • Stop use aned ask a doctor if

    •  condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
  • Keep out of reach of children

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

  • Directions

    apply liberally as often as necessary

  • Inactive ingredients

    water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, Avena sativa (oat) kernel flour, benzyl alcohol, sodium chloride 

  • claim

    Made in the USA with US and foreign components

  • Adverse Reactions

    Distributed by

    AMERICAN SALES CO

    4201 WALDEN AVE

    LANCASTER, NY 14086

    QUALITY GUARANTEED OR YOUR MONEY BACK.

    619.003/AC rev 2

  • principal display panel

    CAREONE

    Oatmeal

    Hand & Body

    DailyMoisturizing

    Skin Protectant Lotion

    Relieves and Protects Dry Skin

    Dermatologist Tested

    Fragrance Free

    Hypoalergenic

    12 FL OZ (354 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    DAILY MOISTURIZING 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-619
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    glycerin (UNII: PDC6A3C0OX)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OATMEAL (UNII: 8PI54V663Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-619-40354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/15/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/15/2012
    Labeler - American Sales Co (809183973)
    Registrant - Vi Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon790752542manufacture(41520-619)
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