Label: INSTANT FOAM- benzalkonium chloride liquid
EPIC- benzalkonium chloride soap

  • Contains inactivated NDC Code(s)
    NDC Code(s):     74146-234-21, 74146-234-22, 74146-234-23, 74146-234-24, view more
    74146-234-25, 74146-234-26, 74146-234-27, 74146-234-28, 74146-234-29, 74146-234-30, 74146-234-31, 74146-234-32, 74146-236-01, 74146-236-02, 74146-236-03, 74146-236-04, 74146-236-05, 74146-236-06, 74146-236-07, 74146-236-08, 74146-236-09, 74146-236-10, 74146-236-11, 74146-236-12, 74146-236-13, 74146-236-14, 74146-236-15, 74146-236-16, 74146-236-17, 74146-236-18, 74146-236-19, 74146-236-20
  • Packager: GM Industrial, 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 January 27, 2021

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

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  • BOXED WARNING (What is this?)

    236 Drug Facts Box

    Benzalkonium Chloride 0.1%

    Antiseptic

    Uses

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use

    For external use only

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children

    In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

    Directions

    • Wet hands and forearms
    • Apply enough product to adequately cover the entire surfaces of the hands and forearms
    • Scrub thoroughly for at least 30 seconds (include the fingernails and the cuticles)
    • Rinse thoroughly with water.

    Other Information

    • Store in a cool dry place below 104°F

    Inactive Ingredients

    Water, Amines, C10-C16-alkyldimethyl, N,oxides, PEG-10 Sorbitan Laurate, C9-11 Pareth-6, Undeceth-5, Triethanolamine, Hydroxypropyl Methylcellulose, Sodium Chloride, DMDM Hydantoin.

  • BOXED WARNING (What is this?)

    234 Drug Facts Box

    Benzalkonium Chloride 0.1%

    Antiseptic

    Uses

    • For hand sanitizing to decrease bacteria on the skin
    • Recommended for repeated use

    For external use only. Do not use in eyes.

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if 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.

    Directions

    • Pump a small amount of foam into palm of hand
    • Rub thoroughly over all surfaces of both hands
    • Rub hands together briskly until dry.

    Inactive Ingredients

    Water, Cocamidopropyl PG-dimonium chloride phosphate, Dihydroxyethyl cocamine oxide, Acetamidoethoxyethanol, Citric acid.

  • PRINCIPAL DISPLAY PANEL

    1 GAL NDC: 74146-236-01 1 GAL NDC: 74146-236-01

  • PRINCIPAL DISPLAY PANEL

    1 GAL Box NDC: 74146-236-02 1 GAL Box NDC: 74146-236-021 GAL Box NDC: 74146-236-02

  • PRINCIPAL DISPLAY PANEL

    1 GAL NDC: 74146-236-03 1 GAL NDC: 74146-236-03

  • PRINCIPAL DISPLAY PANEL

    1 GAL Box NDC: 74146-236-04 1 GAL Box NDC: 74146-236-04

  • PRINCIPAL DISPLAY PANEL

    5 GAL NDC: 74146-236-05 5 GAL NDC: 74146-236-05

  • PRINCIPAL DISPLAY PANEL

    5 GAL NDC: 74146-236-06 5 GAL NDC: 74146-236-06

  • PRINCIPAL DISPLAY PANEL

    55 GAL NDC: 74146-236-07 55 GAL NDC: 74146-236-07

  • PRINCIPAL DISPLAY PANEL

    55 GAL NDC: 74146-236-08 55 GAL NDC: 74146-236-08

  • PRINCIPAL DISPLAY PANEL

    30 GAL NDC: 74146-236-09 30 GAL NDC: 74146-236-09

  • PRINCIPAL DISPLAY PANEL

    30 GAL NDC: 74146-236-10 30 GAL NDC: 74146-236-10

  • PRINCIPAL DISPLAY PANEL

    15 GAL NDC: 74146-236-11 15 GAL NDC: 74146-236-11

  • PRINCIPAL DISPLAY PANEL

    15 GAL NDC: 74146-236-12 15 GAL NDC: 74146-236-12

  • PRINCIPAL DISPLAY PANEL

    3.55 L Jug NDC: 74146-236-13 3.55 L Jug NDC: 74146-236-13

  • PRINCIPAL DISPLAY PANEL

    3.55 L Jug Box NDC: 74146-236-14 3.55 L Jug Box NDC: 74146-236-14

  • PRINCIPAL DISPLAY PANEL

    3.55 L Jug NDC: 74146-236-15 3.55 L Jug NDC: 74146-236-15

  • PRINCIPAL DISPLAY PANEL

    3.55 L Jug Box NDC: 74146-236-16 3.55 L Jug Box NDC: 74146-236-16

  • PRINCIPAL DISPLAY PANEL

    2.5 L NDC: 74146-236-17 2.5 L NDC: 74146-236-17

  • PRINCIPAL DISPLAY PANEL

    2.5 L Jug Box NDC: 74146-236-18 2.5 L Jug Box NDC: 74146-236-18

  • PRINCIPAL DISPLAY PANEL

    2.5 L Jug NDC: 74146-236-19 2.5 L Jug NDC: 74146-236-19

  • PRINCIPAL DISPLAY PANEL

    2.5 L Jug Box NDC: 74146-236-20 2.5 L Jug Box NDC: 74146-236-20

  • PRINCIPAL DISPLAY PANEL

    1000 mL NDC: 1000 mL NDC: 74146-234-2974146-234-29

  • PRINCIPAL DISPLAY PANEL

    1 gal NDC 74146-234-21 1 GAL NDC: 74146-234-21

  • PRINCIPAL DISPLAY PANEL

    5 gal NDC 74146-234-25 5 GAL NDC: 74146-234-25

  • PRINCIPAL DISPLAY PANEL

    55 gal NDC 74146-234-27 55 GAL NDC: 74146-234-27

  • PRINCIPAL DISPLAY PANEL

    1000 mL NDC 74146-234-30 1000 mL NDC:74146-234-30

  • PRINCIPAL DISPLAY PANEL

    1 GAL NDC: 74146-234-221 Gal NDC 74146-234-22

  • PRINCIPAL DISPLAY PANEL

    1000 mL NDC: 74146-234-311000 mL NDC 74146-234-31

  • PRINCIPAL DISPLAY PANEL

    5 GAL NDC: 74146-234-265 Gal NDC 74146-234-26

  • PRINCIPAL DISPLAY PANEL

    55 Gal NDC 74146-234-28 55 GAL NDC: 74146-234-28

  • PRINCIPAL DISPLAY PANEL

    1 gal NDC 74146-234-23 1 GAL NDC: 74146-234-23

  • PRINCIPAL DISPLAY PANEL

    1000 mL NDC 74146-234-32 1000 mL NDC: 74146-234-32

  • PRINCIPAL DISPLAY PANEL

    1 GAL NDC: 74146-234-241 Gal NDC 74146-234-24

  • INGREDIENTS AND APPEARANCE
    INSTANT FOAM 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74146-234
    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
    ACETAMIDOETHOXYETHANOL (UNII: LVX2APC4XR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74146-234-224 in 1 BOX05/18/2020
    1NDC:74146-234-213785.41 mL in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:74146-234-244 in 1 BOX05/18/2020
    2NDC:74146-234-233785.41 mL in 1 CONTAINER; Type 0: Not a Combination Product
    3NDC:74146-234-2518927.1 mL in 1 DRUM; Type 0: Not a Combination Product05/18/2020
    4NDC:74146-234-2618927.1 mL in 1 DRUM; Type 0: Not a Combination Product05/18/2020
    5NDC:74146-234-27208198 mL in 1 DRUM; Type 0: Not a Combination Product05/18/2020
    6NDC:74146-234-28208198 mL in 1 DRUM; Type 0: Not a Combination Product05/18/2020
    7NDC:74146-234-304 in 1 BOX05/18/2020
    7NDC:74146-234-291000 mL in 1 JUG; Type 0: Not a Combination Product
    8NDC:74146-234-324 in 1 BOX05/18/2020
    8NDC:74146-234-311000 mL in 1 JUG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/18/2020
    EPIC 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74146-236
    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
    PEG-10 SORBITAN LAURATE (UNII: 4Z93U4C2WN)  
    UNDECETH-5 (UNII: DMW92U6F5Q)  
    C9-11 PARETH-6 (UNII: KCE0V8JT7W)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    (C10-C16)ALKYLDIMETHYLAMINE OXIDE (UNII: LF6BKC321J)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74146-236-024 in 1 BOX08/26/2020
    1NDC:74146-236-013785.41 mL in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:74146-236-044 in 1 BOX08/26/2020
    2NDC:74146-236-033785.41 mL in 1 CONTAINER; Type 0: Not a Combination Product
    3NDC:74146-236-0518927.1 mL in 1 DRUM; Type 0: Not a Combination Product08/26/2020
    4NDC:74146-236-0618927.1 mL in 1 DRUM; Type 0: Not a Combination Product08/26/2020
    5NDC:74146-236-07208198 mL in 1 DRUM; Type 0: Not a Combination Product08/26/2020
    6NDC:74146-236-08208198 mL in 1 DRUM; Type 0: Not a Combination Product08/26/2020
    7NDC:74146-236-09113562 mL in 1 DRUM; Type 0: Not a Combination Product08/26/2020
    8NDC:74146-236-10113562 mL in 1 DRUM; Type 0: Not a Combination Product08/26/2020
    9NDC:74146-236-1156781.2 mL in 1 DRUM; Type 0: Not a Combination Product08/26/2020
    10NDC:74146-236-1256781.2 mL in 1 DRUM; Type 0: Not a Combination Product08/26/2020
    11NDC:74146-236-144 in 1 BOX08/26/2020
    11NDC:74146-236-133550 mL in 1 JUG; Type 0: Not a Combination Product
    12NDC:74146-236-164 in 1 BOX08/26/2020
    12NDC:74146-236-153550 mL in 1 JUG; Type 0: Not a Combination Product
    13NDC:74146-236-184 in 1 BOX08/26/2020
    13NDC:74146-236-172500 mL in 1 JUG; Type 0: Not a Combination Product
    14NDC:74146-236-204 in 1 BOX08/26/2020
    14NDC:74146-236-192500 mL in 1 JUG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/26/2020
    Labeler - GM Industrial, Inc. (025827197)
    Registrant - GM Industrial, Inc. (025827197)
    Establishment
    NameAddressID/FEIBusiness Operations
    GM Industrial, Inc.025827197manufacture(74146-234, 74146-236) , label(74146-234, 74146-236) , pack(74146-234, 74146-236)
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