Label: BCP- benzalkonium chloride cloth

  • 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 July 29, 2020

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  • ACTIVE INGREDIENTS

    Benzalkonium chloride

    Ethyl Alcohol

  • INACTIVE INGREDIENTS

    WATER, ALOE VERA LEAF, ANHYDROUS CITRIC ACID, DIMETHICONE, GLYCERIN, EDETATE SODIUM TETRAHYDRATE, ALPHA TOCOPHEROL ACETATE, HYDANTOIN, POLYSORBATE 20, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE

  • WARNINGS AND PRECAUTIONS

    Children under 6 years of age should be supervised when using.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame

  • DOSAGE AND ADMINISTRATION

    APPLY TO HANDS AND ALLOW TO DRY WITHOUT WIPING.

  • PURPOSE

    ANTIBACTERIAL

  • STOP USE

    STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH DEVELOPS AND CONTINUES FOR MORE THAN 72 HOURS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • INDICATIONS AND USAGE

    APPLY TO HANDS AND ALLOW TO DRY WITHOUT WIPING.

  • PACKAGE LABEL

    LABEL ANTISEPTIC WIPES

  • INGREDIENTS AND APPEARANCE
    BCP 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78502-7000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.05 g  in 100 g
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 0.08 g  in 100 g
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.005 g  in 100 g
    WATER (UNII: 059QF0KO0R) 93.885 g  in 100 g
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 0.1 g  in 100 g
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 0.1 g  in 100 g
    EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6) 0.008 g  in 100 g
    HYDANTOIN (UNII: I6208298TA) 0.002 g  in 100 g
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.015 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.5 g  in 100 g
    DIMETHICONE (UNII: 92RU3N3Y1O) 0.005 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78502-7000-130 g in 1 BAG; Type 0: Not a Combination Product07/04/2020
    2NDC:78502-7000-240 g in 1 BAG; Type 0: Not a Combination Product07/04/2020
    3NDC:78502-7000-35 g in 1 BAG; Type 0: Not a Combination Product07/04/2020
    4NDC:78502-7000-412 g in 1 BAG; Type 0: Not a Combination Product07/04/2020
    5NDC:78502-7000-520 g in 1 BAG; Type 0: Not a Combination Product07/04/2020
    6NDC:78502-7000-6100 g in 1 BAG; Type 0: Not a Combination Product07/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/04/2020
    Labeler - BELSKIN S. DE, R.L. DE C.V (816649743)
    Registrant - BELSKIN S. DE, R.L. DE C.V (816649743)
    Establishment
    NameAddressID/FEIBusiness Operations
    BELSKIN S. DE, R.L. DE C.V816649743manufacture(78502-7000)
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