Label: ATTIPURE SANITIZER WET 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 April 25, 2020

If you are a consumer or patient please visit this version.

  • Active ingredient[s]

    Benzalkonium Chloride 0.1%

  • Purpose

    Antimicrobial

  • Use[s]

    eliminates harmful germs and bacteria on skin

  • Warnings.

    For external use only.

  • Do not use

    if you are allergic to any of the ingredients

  • When using this product

    do not get into eyes

  • Stop use and ask a doctor

    if irritation or rash appears and lasts

  • Keep out of reach of children.

    If swallowed, get medical help

  • Directions

    Unfold towelette; Wipe hands; Discard after use

  • Inactive ingredients

    Water, Glycerin, Sodium Benzoate, Hydroxyacetophenone

  • Package Label

    350g NDC: 76709-201-01 Label

    700g NDC: 76709-201-02 Label

  • INGREDIENTS AND APPEARANCE
    ATTIPURE SANITIZER WET WIPES 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76709-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE100 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76709-201-01350 g in 1 BOX; Type 0: Not a Combination Product05/12/2020
    2NDC:76709-201-02700 g in 1 BOX; Type 0: Not a Combination Product05/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/12/2020
    Labeler - INVICTA ASIA CO., LTD (695625867)
    Registrant - INVICTA ASIA CO., LTD (695625867)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAMJOO ENTERPRISE688657061manufacture(76709-201)