Label: P.O.V. SPRINGTIME RENEWAL ANTIBACTERIAL FOAMING HAND- benzalkonium chloride soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 13, 2017

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  • Active ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Uses

    helps eliminate bacteria on hands.

  • Warnings

    For external use only.

    When using this product

    avoid contact with eyes. In case of contact, rinse thoroughly with water.

    Stop use and ask a doctor if

    irritation and redness develops and lasts.

    Keep out of reach of children.

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

  • Directions

    • apply onto dry hands.
    • lather and rinse thoroughly.
  • Other information

    store at room temperature.

  • Inactive ingredients

    Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside Hydroxyethylcelluose, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Propylen Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Ext. Violet 2 (CI 60730).

  • Questions or comments?

    1-866-695-3030

  • Label Copy

    Image of the label

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  • INGREDIENTS AND APPEARANCE
    P.O.V. SPRINGTIME RENEWAL ANTIBACTERIAL FOAMING HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-198
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-198-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/10/2017
    2NDC:63148-198-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/10/2017
    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(63148-198)
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