Label: CRISP PEAR- 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 September 11, 2022

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  • Active Ingredient.

    Benzalkonium Chloride (0.13%)

  • Purpose

    Antibacterial

  • Uses

    • For hand washing to decrease bacteria on the skin
  • 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 or redness develops and lasts for more than 72 hours

    Keep out of reach of children.

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

  • Directions

    • Apply onto dry hands
    • Lather and rinse thoroughly with water.
  • Other Information

    Store at room temperature

  • Inactive Ingredients

    Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Polyquatermium-7, Xanthan Gum, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Green 3 (Cl 42053), Yellow 10 (Cl 47005)

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    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    CRISP PEAR 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71141-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE130 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    MORDANT YELLOW 10 (UNII: 3LV23DNR2H)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    WATER (UNII: 059QF0KO0R)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71141-022-02222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/06/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/04/2021
    Labeler - LIDL US LLC (079389709)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture(71141-022)
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