Label: P.O.V ITCH RELIEF BODY- dimethicone, menthol 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 March 29, 2018

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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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