Label: AQUARELLE- benzalkonium chloride cloth

  • NDC Code(s): 70697-805-01, 70697-805-02, 70697-805-03, 70697-805-04, view more
    70697-805-05, 70697-805-06
  • Packager: INDELPA, S.A DE C.V
  • 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 10, 2023

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride....0.125%

  • PURPOSE

    Antibaterial

  • INDICATIONS & USAGE

    For hand washing to decrease bacteria on the skin. May be used on face, arms and legs

  • WARNINGS AND PRECAUTIONS

    for external use only

  • DO NOT USE

    If you are allergic to any of the ingredients

  • WHEN USING

    Di not get into eyes. If contact occurs rinse thoroughly 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

  • INDICATIONS & USAGE

    Throughly wipe hands and face as desired.

    Allow to dry without wiping.

    Discard wipe in trash receptacle after use. Do not flush

  • STORAGE AND HANDLING

    Store at room temperature. Cold weather may cloud this product. It´s antisceptic properties are not affected

  • INACTIVE INGREDIENT

    Demineralised water, Propylene Glycol, Polysorbate 20, Sodium Cocoamphoacetate, Methylchloroisothiazolinone / Methylisothiazolinone, Fragrance, Aloe Vera Extract, Tretasodium EDTA, Citric Acid, D-alpha Tocopheryl Acetate.

  • DOSAGE & ADMINISTRATION

    Dossage: swab

    Administration: Topical

  • INSTRUCTIONS FOR USE

    To dispense wipe: Peel back front label slowly. Remove wipes

    To resela Pouch: Firmly run thumb over the label

  • WARNINGS

    For external use only

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    AQUARELLE 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70697-805
    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
    WATER (UNII: 059QF0KO0R) 98.567 mg  in 100 mg
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.05 mg  in 100 mg
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.3 mg  in 100 mg
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 0.01 mg  in 100 mg
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.018 mg  in 100 mg
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W) 0.1 mg  in 100 mg
    SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674) 0.2 mg  in 100 mg
    EDETATE SODIUM (UNII: MP1J8420LU) 0.03 mg  in 100 mg
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.5 mg  in 100 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70697-805-0130 in 1 CASE11/02/2020
    115 in 1 PACKAGE
    10.375 mg in 1 POUCH; Type 0: Not a Combination Product
    2NDC:70697-805-0224 in 1 CASE11/02/2020
    20.375 mg in 1 POUCH; Type 0: Not a Combination Product
    3NDC:70697-805-0312 in 1 CASE11/02/2020
    30.375 mg in 1 POUCH; Type 0: Not a Combination Product
    4NDC:70697-805-0424 in 1 CASE11/27/2020
    40.375 mg in 1 POUCH; Type 0: Not a Combination Product
    5NDC:70697-805-0516 in 1 BOX10/01/2020
    51 in 1 PACKAGE
    50.3 mg in 1 POUCH; Type 0: Not a Combination Product
    6NDC:70697-805-0624 in 1 CASE11/01/2021
    60.375 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 finalpart333E10/01/2020
    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.V811072487manufacture(70697-805) , analysis(70697-805) , pack(70697-805) , label(70697-805)
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