Label: MARCS DAILY MOISTURIZING WITH NATURAL COLLOIDAL OATMEAL- 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 November 7, 2019

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  • Marc's Daily Moisturizing Lotion with Natural Colloidal Oatmeal – Drug Facts

  • Active ingredients

    Dimethicone 1.3%

  • Purpose

    Skin Protectant

  • Uses

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

    For external use only

  • DO NOT USE

    Do not use on • deep or puncture wounds • animal bites • serious burns.

  • 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 seven days or clear up and occur again within a few days.

  • 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.

  • Directions

    • apply as needed to hands or body when skin feels dry or irritated.
  • Other information

    • May stain or damage some fabrics, materials or surfaces.
  • Inactive ingredients

    water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, avena sativa (oat) kernel flour, magnesium
    aluminum silicate, sodium chloride, benzyl alcohol.

  • PRINCIPAL DISPLAY PANEL

    Marc's Daily Moisturizing Lotion with Natural Colloidal Oatmeal

    18 FL OZ (532ml)

    NDC 68998-200-43

    Label

  • INGREDIENTS AND APPEARANCE
    MARCS  DAILY MOISTURIZING WITH NATURAL COLLOIDAL OATMEAL
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-200
    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
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    OATMEAL (UNII: 8PI54V663Y)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68998-200-43532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/09/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/09/2019
    Labeler - MARC GLASSMAN, INC. (094487477)
    Registrant - Fruit Of The Earth, Inc. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(68998-200)
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