INSTANT FOAM- benzalkonium chloride liquid 
EPIC- benzalkonium chloride soap 
GM Industrial, Inc.

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.

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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.

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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)

Revised: 1/2021
Document Id: a8c7545c-1553-beac-e053-2995a90a3de3
Set id: a212e12c-2bef-f3dd-e053-2995a90adcd8
Version: 3
Effective Time: 20210127
 
GM Industrial, Inc.