Label: CLORALEN TM ANTIBACTERIAL WIPES- benzalkonium chloride liquid

  • 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 January 13, 2022

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  • PURPOSE

    Antibacterial

  • ACTIVE INGREDIENT

    BENZALKONIUM, CHLORIDE 0.125%

  • INDICATIONS & USAGE

    Hand sanitizer to help reduce bacteria on the skin

  • WARNINGS

    For external use only.

  • DO NOT USE

    If you are allergic to any of the ingredients

  • WHEN USING

    Do not get into eyes.

    If contact occurs, rinse throughly with water

  • STOP USE

    If irritation or rash develops and continues for more than 72 hours

  • ASK DOCTOR

    If irritation or rash develops and continues for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

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

  • INSTRUCTIONS FOR USE

    - wet hands throughly with product and allow to dry.

    -discard wipe in trash receptacle after use. Do not flush

    - chuldren under 6 years af age should be supervised whe using this product

  • INACTIVE INGREDIENT

    water, propylene glycol USP, polysorbate 20, sodium cocoamphoacetate, fragrance, methylchloroisothiazolinone / methylisothiazolinone, aloe vera extract, tetrasodium EDTA, citric acid, acetate D alpha- tocopherol

  • DOSAGE & ADMINISTRATION

    Topical admistration

  • PRINCIPAL DISPLAY PANEL

    DISPLAY CLORALEN

  • INGREDIENTS AND APPEARANCE
    CLORALEN TM ANTIBACTERIAL WIPES 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70697-802
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.125 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.01 mg  in 100 mg
    EDETATE SODIUM (UNII: MP1J8420LU) 0.03 mg  in 100 mg
    WATER (UNII: 059QF0KO0R) 98.567 mg  in 100 mg
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W) 0.1 mg  in 100 mg
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.05 mg  in 100 mg
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.018 mg  in 100 mg
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) 0.1 mg  in 100 mg
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.3 mg  in 100 mg
    SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674) 0.2 mg  in 100 mg
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.05 mg  in 100 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70697-802-0124 in 1 CASE09/01/2020
    10.375 mg in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/01/2020
    Labeler - INDELPA, S.A DE C.V (811072487)
    Registrant - INDELPA, S.A DE C.V (811072487)
    Establishment
    NameAddressID/FEIBusiness Operations
    INDELPA, S.A DE C.V811072487pack(70697-802) , manufacture(70697-802) , label(70697-802) , analysis(70697-802)
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