Label: FAREWELL COLLECTION- antiseptic hand soap 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 December 14, 2022

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  • Active Ingredient(s)

    Benzalkonium chloride 0.1%

  • Purpose

    Antiseptic

  • Use

    To help reduce bacteria on hands.

  • Warnings

    For external use only.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • 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 1 800-222-1222

  • Directions

    Apply on hands thoroughly, wash and rinse afterward.

    Children under 6 years of age should be supervised when using this product.

  • Other information

    • Store between 15 and 30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    acrylates copolymer, aloe barbadensis leaf extract, chlorphenesin, cocamidopropyl betaine, disodium EDTA, glycerin, maltodextrin, panthenol, PEG-40 hydrogenated castor oil, phenoxyethanol, PPG-26-Buteth-26, purified water USP, sodium benzoate, sodium hydroxide, sodium lauryl sulfate, tocopheryl acetate

  • Package Label - Principal Display Panel

    250 mL NDC:12961-116-11250 mL NDC:81892-116-11

  • INGREDIENTS AND APPEARANCE
    FAREWELL COLLECTION 
    antiseptic hand soap soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81892-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81892-116-11250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/20/2021
    Labeler - Paveemol Company Limited (660079138)
    Establishment
    NameAddressID/FEIBusiness Operations
    Paveemol Company Limited660079138manufacture(81892-116)
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