Label: MEDICALLY MINDED- 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 4, 2020

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  • DOSAGE AND ADMINISTRATION

    APPLY TO HANDS

    ALLOW TO DRY WITHOUT WIPING

  • WARNINGS AND PRECAUTIONS

    WHEN USING THIS PRODUCT DO NOT GET INTO EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

    CHILDREN UNDER 2 YEARS ASK A DOCTOR BEFORE USE

  • WARNINGS

    FOR EXTERNAL USE ONLY

  • KEEP OUT OF REACH OF CHILDREN

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • STOP USE AND ASK A DOCTOR

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

  • PURPOSE

    ANTIMICROBIAL AGENT

  • ACTIVE INGREDIENT

    BENZALKONIUM CHLORIDE

    ETHYL ALCOHOL

  • INACTIVE INGREDIENT

    WATER
    ALOE VERA (ALOE BARBADENSIS) LEAF JUICE
    ANHYDROUS CITRIC ACID
    DIMETHICONE
    ETHYLENE DIAMINE TETRAACETIC ACID TETRASODIUM SALT (EDTA-4Na)
    HYDANTOINE
    POLYSORBATE 20
    TOCOPHERYL ACETATE (VITAMIN E)
    GLYCERIN
    FRAGRANCE
    METHYLCHLOROISOTHIAZOLINONE
    METHYLISOTHIAZOLINONE

  • INDICATIONS AND USAGE

    APPLY TO HANDS

    ALLOW TO DRY WITHOUT WIPING

  • PACKAGE LABEL

    MEDICALLY MINDED ANTISEPTIC WIPES 40

  • INGREDIENTS AND APPEARANCE
    MEDICALLY MINDED 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78502-6000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.25 g  in 100 g
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 93.885 g  in 100 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.05 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.5 g  in 100 g
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 0.1 g  in 100 g
    DIMETHICONE (UNII: 92RU3N3Y1O) 0.005 g  in 100 g
    EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6) 0.008 g  in 100 g
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 0.1 g  in 100 g
    HYDANTOIN (UNII: I6208298TA) 0.002 g  in 100 g
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.015 g  in 100 g
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.005 g  in 100 g
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 0.08 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78502-6000-640 g in 1 BAG; Type 0: Not a Combination Product06/28/2020
    2NDC:78502-6000-730 g in 1 BAG; Type 0: Not a Combination Product06/28/2020
    3NDC:78502-6000-820 g in 1 BAG; Type 0: Not a Combination Product06/28/2020
    4NDC:78502-6000-910 g in 1 BAG; Type 0: Not a Combination Product06/28/2020
    5NDC:78502-6000-11 g in 1 BAG; Type 0: Not a Combination Product06/28/2020
    6NDC:78502-6000-25 g in 1 BAG; Type 0: Not a Combination Product06/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/28/2020
    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(78502-6000)