P.O.V. BABY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [APOLLO HEALTH AND BEAUTY CARE INC.]

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  • P.O.V. BABY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [APOLLO HEALTH AND BEAUTY CARE INC.]

P.O.V. BABY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [APOLLO HEALTH AND BEAUTY CARE INC.]
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NDC 63148-319-18
Set ID fe92bccb-48eb-4277-bf5d-3c298304cd09
Category HUMAN OTC DRUG LABEL
Packager Apollo Health and Beauty Care Inc.
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active ingredient

    Dimethicone 1.2%

    Purpose

    Skin Protectant

  • Uses

    temporarily protects and helps relieve chapped or cracked skin, and helps protect from the drying effects of wind and cold.

  • Warnings

    For external use only.

    When using this product

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

    Stop use and ask a doctor if

    condition worsens, or if irritation or redness develops and lasts more than 7 days, or clears up and recurs 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.

  • Other information

    store at room temperature.

  • Inactive ingredients

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

  • Questions or comments?

    1-866-695-3030

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    P.O.V. BABY MOISTURIZING FRAGRANCE FREE 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-319
    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)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    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:63148-319-18532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/24/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/24/2017
    Labeler - Apollo Health and Beauty Care Inc. (201901209)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(63148-319)
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