Label: FEEL CLEAN ANTISEPTIC HAND WIPES- benzalkonium chloride cloth

  • 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, 2022

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

  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.1%

    Purpose

    Antiseptic

  • Use

    for hand washing to decrease bacteria on the skin.

  • Warnings

    For external use only.

    Do not use 

    in the eyes.

    Stop use and ask a doctor if:

    • irritation and redness develop
    • condition persists for more than 72 hours.

    Keep out of reach of children. 

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

  • Direction

    Wet hands thoroughly with product and allow to dry without wiping.

  • Other information

    • store in a cool, well ventilated place, away from direct sunlight and in the original closed packaging.
    • use within 24 months of the date of manufacture orinted on the packaging
  • Inactive ingredients

    aloe vera extract, alpha isomethyl ionone, benzyl salicylate, butylparaben, butylphenyl methylpropional, citronellol, ethylparaben, fragrance, geraniol, hexyl cinnamal, isobutylparaben, linalool, methylisothiazolinone, methylparaben, PEG-40 hydrogenated castor oil, phenoxyethanol, polysorbate 20, propylene glycol, propylparaben, saccharomyces ferment, tea tree oil, tetrasodium EDTA, water

  • Package Labeling

    Lable

  • Package Labeling:74883-001-02

    Box

  • INGREDIENTS AND APPEARANCE
    FEEL CLEAN ANTISEPTIC HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74883-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GERANIOL (UNII: L837108USY)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74883-001-0116 in 1 BAG05/15/2020
    13.44 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:74883-001-021 in 1 PACKAGE07/30/2020
    23.44 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/15/2020
    Labeler - FW Industria e Comercio de Produtos de Higiene S A (899612211)