Label: 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 July 21, 2020

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

  • 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)