Label: FINIPIL LAIT 50- benzethonium chloride cream

  • NDC Code(s): 53228-050-01, 53228-050-02
  • Packager: Equibal, Inc.
  • 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 October 22, 2022

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

  • Active Ingredient

    DRUG FACTS

    Active Ingredient

    Benzethonium Chloride 0.2% w/w

  • Purpose

    Purpose

    Antiseptic

  • 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.

  • Use(s)

    Use(s)

    • first aid to help prevent bacterial contamination in minor cuts, scrapes and burns.
    • cools, soothes and moisturizes after hair removal.
    • recommended for repeated use.
  • Warnings Do not use in conjunction

    Warnings

    For external use only

    Do not use in conjunction

    with products containing acids


  • Ask a doctor if

    Ask a doctor if pregnant or breast feeding,

  • Stop use and ask a doctor if

    Stop use and ask a doctor if

    irritation and redness develop

  • Directions

    Directions

    Apply a small amount of this product on the area daily.

  • When using this product

    When using this product do not get into eyes.

    If contact occurs, rinse eyes thoroughly with water.

  • Inactive ingredients

    Inactive ingredients

    Behentrimonium methosulfate, Bisabolol, Butylene Glycol, Cetyl Alcohol, Chlorhexidine Gluconate, Dimethicone, Matricaria (Chamomile Recutita) Extract, Menthyl Lactate, Octyldodecanol, Phenoxyethanol, Polyquarternium-37, Stearic Acid, Witch Hazel (Hamamelis Virginiana) Extract

  • finipil LAIT 50 Product Label

    finipil®

    soothes          antiseptic

    moisturizes   cream

           protects

           against

           infection

           LAIT 50

            ●

    Noncomedogenic

    1.5 fl oz 44 ml

    DRUG FACTS

    Active Ingredient                                             Purpose

    Benzethonium Chloride 0.2% w/w           Antiseptic

    Uses(s)

    • first aid to help prevent bacterial contamination in minor cuts, scrapes, and burns.
    • cools, soothes, and moisturizes after hair removal.
    • recommended for repeated use.

    Warnings

    For external use only

    Ask a doctor if pregnant or breast feeding.

    When using this product do not get into eyes.

    if contact occurs, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    irritation and redness develop

    Do not use in conjunction

    with products containing acids.

    Keep out of reach of children

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

    Directions

    Apply a small amount of this product on the area daily.

    Inactive Ingredients

    Behentrimonium Methosulfate, Bisabolol, Butylene Glycol, Cetyl Alcohol, Chlorhexidine Gluconate, Dimethicone, Matricaria (Chamomile Recutital) Extract, Menthyl Lactate, Octylodecanoil, Phenoxyethanol, Polyquaterniuim-37, Stearic Acid, Water, Witch Hazel (Hamamelis Virginiana) Extract

    equibal labs

    800-247-2405

    nufree.com

    Made in U.S.A.                                 

    not tested on animals

    patent# 8,603,550

    Equibal finipilLait50

    Equibal finipilLait50 2.5fl

  • INGREDIENTS AND APPEARANCE
    FINIPIL LAIT 50 
    benzethonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53228-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE195 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYQUATERNIUM-37 (25000 MPA.S) (UNII: 31L31U8285)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53228-050-0144 mL in 1 TUBE; Type 0: Not a Combination Product03/01/2013
    2NDC:53228-050-0275 mL in 1 TUBE; Type 0: Not a Combination Product03/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/2013
    Labeler - Equibal, Inc. (144679883)
    Registrant - Equibal, Inc. (144679883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Equibal, Inc.144679883manufacture(53228-050)