Label: ULTRACLEAN- sanitizer wet wipes swab

  • 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 June 20, 2020

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  • Active Ingredient(s)

    Benzalkonium chloride 0.115%

  • Purpose

    Antiseptic

  • Use

    For sanitizing to help reduce bacteria on the skin. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

    Not edible, don't drink. Do not use in ears or mouth.

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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 the product and allow it to dry, discard after use.

    Children under 6 years of age should be supervised when using UltraClean Products.

  • Other information

    • Avoid excessive heat or freezing. Store between 15-30 C.
    • Dispose the used wipe in trash, do not flush it into the toilet.
    • The product may discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water, citric acid, lime oil, Cocamidopropyl betaine, Phenoxyethanol, Polysorbate 20, peg-7 glyceryl cocoate

  • Package Label - Principal Display Panel

    72 PCS NDC: 77222-224-0172 PCS NDC: 77222-224-01

  • INGREDIENTS AND APPEARANCE
    ULTRACLEAN 
    sanitizer wet wipes swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77222-224
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.115 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LIME OIL (UNII: UZH29XGA8G)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77222-224-0172 in 1 PACKAGE06/20/2020
    1100 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/20/2020
    Labeler - SIRIUS ENDUSTRI YATIRIMLARI VE PLASTIK SANAYI ANONIM SIRKETI (520078677)
    Establishment
    NameAddressID/FEIBusiness Operations
    SIRIUS ENDUSTRI YATIRIMLARI VE PLASTIK SANAYI ANONIM SIRKETI520078677manufacture(77222-224)
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