P.O.V ITCH RELIEF BODY (DIMETHICONE, MENTHOL) LOTION [APOLLO HEALTH AND BEAUTY CARE INC.]

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P.O.V ITCH RELIEF BODY (DIMETHICONE, MENTHOL) LOTION [APOLLO HEALTH AND BEAUTY CARE INC.]
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NDC 63148-562-14
Set ID 0b394675-00de-4d9c-bb31-dc79218de647
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 ingredients

    Dimethicone 5.0%, Menthol 0.5%

    Purpose

    Skin Protectant, Anti-itch

  • Uses

    • temporarily protects and helps relieve chapped or cracked skin.
    • temporarily relieves itching associated with: minor skin irritations, minor burns, rashes due to poison ivy, oak and sumac
    • insect bites
    • sunburn
  • Warnings

    For external use only

    When using this product

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

    Do not use on

    • deep or puncture wournds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness, irritation, swelling or pain persists or increases

    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), Cetearyl Alcohol, Cetyl Alcohol, Polysorbate 60, Distearyldimonium Chloride, Glycerin, Stearamidopropyl PG-Dimonium Chloride Phosphate, Petrolatum, Aloe Barbadensis Leaf Juice, Stearyl Alcohol, Steareth-2, Steareth-21, Tocopheryl Acetate, Tetrasodium EDTA, Benzyl Alcohol, Iodopropynyl Butylcarbamate, Fragrance (Parfum).

  • Questions or comments?

    1-866-695-3030

  • Label Copy

    image of the label

  • INGREDIENTS AND APPEARANCE
    P.O.V ITCH RELIEF BODY 
    dimethicone, menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-562
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE50 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: W6000VEI5Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-562-14414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/28/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/28/2018
    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(63148-562)
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