Label: LIFE IS HEALED DAILY MOISTURIZING- dimethicone lotion

  • NDC Code(s): 63148-028-05
  • Packager: Apollo Health and Beauty Care
  • 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 September 12, 2022

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  • Active Ingredient.

    Dimethicone (1.2%)

  • Purpose

    Skin Protectant

  • Uses

    helps prevent and temporarily protects chafed, chapped or cracked skin.

  • Warnings

    For external use only.

    When using this product

    Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop using this product and ask a doctor if

    condition worsens or symptoms persist for more than seven days or occur again within a few days.

    Keep out of reach of children

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    apply as needed.

  • Inactive Ingredients

    Water (Aqua), Glycerin, Petrolatum, Distearyldimonium Chloride, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Sodium Chloride, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.

  • PDP05

    PDP05

  • INGREDIENTS AND APPEARANCE
    LIFE IS HEALED   DAILY MOISTURIZING
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-028
    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)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OATMEAL (UNII: 8PI54V663Y)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-028-05532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/20/2021
    Labeler - Apollo Health and Beauty Care (201901209)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture(63148-028)
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