Label: LITTLE BUDDY IN A LITTLE TUBBY- hand sanitizing towelettes cloth

  • NDC Code(s): 64321-123-70
  • Packager: Continental Research Corp
  • 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 February 18, 2023

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  • Active Ingredient(s)

    Benzalkonium chloride 0.12%

  • Purpose

    Antiseptic

  • Use

    For handwashing to decrease bacteria on the skin. • After changing diapers. • After assisting ill persons. • Before contact with a person under medical care or treatment. • Recommended for repeat use.

  • Warnings

    For external use only.

  • Do not use

    Do not use in the eyes.

  • WHEN USING

    When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

  • 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.

  • Directions

    Wet hands thoroughly with product and allow to dry. • Children under six years of age should be

    supervised when using this product.

  • Other information

    Store in a cool, dry place.

  • Inactive ingredients

    Water, Aloe Barbadensis Leaf Juice, Polysorbate 20, Glycerin, Potassium Sorbate, Fragrance, Citric Acid, Disodium EDTA, Tocopheryl Acetate (Vitamin E).

  • Package Label - Principal Display Panel

    70 PCS NDC:64321-123-70

    70 PCS NDC:64321-123-70

  • INGREDIENTS AND APPEARANCE
    LITTLE BUDDY IN A LITTLE TUBBY 
    hand sanitizing towelettes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64321-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64321-123-7070 in 1 CANISTER02/18/2023
    170 mL in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/18/2023
    Labeler - Continental Research Corp (071988653)
    Establishment
    NameAddressID/FEIBusiness Operations
    Athea Laboratories Inc006117816manufacture(64321-123)
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