Label: EQUATE DAILY MOISTURIZING DIMETHICONE SKIN PROTECTANT- dimethicone lotion

  • NDC Code(s): 49035-575-43, 49035-575-44
  • Packager: Walmart stores Inc.
  • 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 February 13, 2020

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

  • Active ingredients

    Dimethicone 1.2%

  • Purpose

    Skin Protectant

  • Uses

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

    When using this product • do not get into eyes

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

  • 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.

    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 some fabrics

  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    Equate Daily Moisturizing Dimethicone Skin Protectant Label

  • INGREDIENTS AND APPEARANCE
    EQUATE DAILY MOISTURIZING DIMETHICONE SKIN PROTECTANT 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-575
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OATMEAL (UNII: 8PI54V663Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-575-43532 mL in 1 BOTTLE; Type 0: Not a Combination Product02/07/2019
    2NDC:49035-575-44976 mL in 1 BOTTLE; Type 0: Not a Combination Product02/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/07/2019
    Labeler - Walmart stores Inc. (051957769)
    Registrant - FRUIT OF THE EARTH, INC. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(49035-575)