Label: DAILY MOISTURIZING- dimethicone lotion

  • NDC Code(s): 36800-619-40, 36800-619-44
  • Packager: TopCo Associates LLC
  • Category: HUMAN OTC DRUG LABEL

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 March 21, 2022

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  • Active ingredient

    Dimethicone 1.3%

  • Purpose

    Skin Protectant

  • Uses

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

    For external use only

  • Do not use on

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

    keep out of eyes

  • Stop use and ask a doctor if

    condition worsens or does not improve within seven 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

  • Disclaimer

    This product is not manufactured or distributed by Johnon & Johnson Consumer Products Company, distributor of Aveno Daily Moisturizing Lotion

    Made in the USA with US and foreign components.

    DIST. BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    QUESTIONS? 1-888-423-0139 topcare@topco.com

    www.topccarebrand.com

  • principal display panel

    TOPCARE beauty

    DAILY MOISTURIZING LOTION

    Dimethicone Skin Protectant

    Compare to AVEENO

    With natural colloidal oatmeal

    Dermatologist tested

    Fragrance Free

    12 FL OZ (354 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    DAILY MOISTURIZING 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-619
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE13.13 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:36800-619-40354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/03/2010
    2NDC:36800-619-44532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/03/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/03/2010
    Labeler - TopCo Associates LLC (006935977)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(36800-619)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(36800-619)
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