INSTANT FOAM- benzalkonium chloride liquid EPIC- benzalkonium chloride soap

Epic by

Drug Labeling and Warnings

Epic by is a Otc medication manufactured, distributed, or labeled by GM Industrial, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BOXED WARNING

(What is this?)

Epic 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, (C10-C16) Alcohol Ethoxylate, Sulfated, Sodium Salt, Cacamide DIPA, Cocamidopropyl Betaine, 1-Dodecanamine, N,N-demiethyl-, N-oxide.

BOXED WARNING

(What is this?)

Instant Foam 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.

PRINCIPAL DISPLAY PANEL

2.5 L NDC: 74146-236-57

PRINCIPAL DISPLAY PANEL

2.5 L NDC: 74146-236-58

PRINCIPAL DISPLAY PANEL

2.5 L NDC: 74146-236-59

PRINCIPAL DISPLAY PANEL

2.5 L NDC: 74146-236-60

PRINCIPAL DISPLAY PANEL

3.5 L NDC: 74146-236-53

PRINCIPAL DISPLAY PANEL

3.5 L NDC: 74146-236-54

PRINCIPAL DISPLAY PANEL

3.5 L NDC: 74146-236-55

PRINCIPAL DISPLAY PANEL

3.5 L NDC: 74146-236-56

PRINCIPAL DISPLAY PANEL

15 gal NDC: 74146-236-51

PRINCIPAL DISPLAY PANEL

15 gal NDC: 74146-236-52

PRINCIPAL DISPLAY PANEL

30 gal NDC: 74146-236-49

PRINCIPAL DISPLAY PANEL

30 gal NDC: 74146-236-50

PRINCIPAL DISPLAY PANEL

55 gal NDC: 74146-236-47

PRINCIPAL DISPLAY PANEL

55 gal NDC: 74146-236-48

PRINCIPAL DISPLAY PANEL

5 gal NDC: 74146-236-45

PRINCIPAL DISPLAY PANEL

5 gal NDC: 74146-236-46

PRINCIPAL DISPLAY PANEL

1 gal NDC: 74146-236-41

PRINCIPAL DISPLAY PANEL

1 gal NDC: 74146-236-42

PRINCIPAL DISPLAY PANEL

1 gal NDC: 74146-236-43

PRINCIPAL DISPLAY PANEL

1 gal NDC: 74146-236-44

PRINCIPAL DISPLAY PANEL

1 gal NDC: 74146-234-21

PRINCIPAL DISPLAY PANEL

1 gal NDC: 74146-234-22

PRINCIPAL DISPLAY PANEL

1 gal NDC: 74146-234-23

PRINCIPAL DISPLAY PANEL

1 gal NDC: 74146-234-24

PRINCIPAL DISPLAY PANEL

5 gal NDC: 74146-234-25

PRINCIPAL DISPLAY PANEL

5 gal NDC: 74146-234-26

PRINCIPAL DISPLAY PANEL

55 gal NDC: 74146-234-27

PRINCIPAL DISPLAY PANEL

55 gal NDC: 74146-234-28

PRINCIPAL DISPLAY PANEL

1 L NDC: 74146-234-29

PRINCIPAL DISPLAY PANEL

1 L NDC: 74146-234-30

PRINCIPAL DISPLAY PANEL

1 L NDC: 74146-234-31

PRINCIPAL DISPLAY PANEL

1 L NDC: 74146-234-32

INGREDIENTS AND APPEARANCE

INSTANT FOAM 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74146-234
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74146-234-22	4 in 1 BOX	05/18/2020
1	NDC: 74146-234-21	3785.41 mL in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 74146-234-24	4 in 1 BOX	05/18/2020
2	NDC: 74146-234-23	3785.41 mL in 1 CONTAINER; Type 0: Not a Combination Product
3	NDC: 74146-234-25	18927.1 mL in 1 DRUM; Type 0: Not a Combination Product	05/18/2020
4	NDC: 74146-234-26	18927.1 mL in 1 DRUM; Type 0: Not a Combination Product	05/18/2020
5	NDC: 74146-234-27	208198 mL in 1 DRUM; Type 0: Not a Combination Product	05/18/2020
6	NDC: 74146-234-28	208198 mL in 1 DRUM; Type 0: Not a Combination Product	05/18/2020
7	NDC: 74146-234-30	4 in 1 BOX	05/18/2020
7	NDC: 74146-234-29	1000 mL in 1 JUG; Type 0: Not a Combination Product
8	NDC: 74146-234-32	4 in 1 BOX	05/18/2020
8	NDC: 74146-234-31	1000 mL in 1 JUG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/18/2020

EPIC 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74146-236
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74146-236-42	4 in 1 BOX	05/18/2020
1	NDC: 74146-236-41	3785.1 mL in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 74146-236-44	4 in 1 BOX	05/18/2020
2	NDC: 74146-236-43	3785.1 mL in 1 CONTAINER; Type 0: Not a Combination Product
3	NDC: 74146-236-45	18927.1 mL in 1 DRUM; Type 0: Not a Combination Product	05/18/2020
4	NDC: 74146-236-46	18927.1 mL in 1 DRUM; Type 0: Not a Combination Product	05/18/2020
5	NDC: 74146-236-47	208198 mL in 1 DRUM; Type 0: Not a Combination Product	05/18/2020
6	NDC: 74146-236-48	208198 mL in 1 DRUM; Type 0: Not a Combination Product	05/18/2020
7	NDC: 74146-236-49	113562 mL in 1 DRUM; Type 0: Not a Combination Product	05/18/2020
8	NDC: 74146-236-50	113562 mL in 1 DRUM; Type 0: Not a Combination Product	05/18/2020
9	NDC: 74146-236-51	56781.2 mL in 1 DRUM; Type 0: Not a Combination Product	05/18/2020
10	NDC: 74146-236-52	56781.2 mL in 1 DRUM; Type 0: Not a Combination Product	05/18/2020
11	NDC: 74146-236-54	4 in 1 BOX	05/18/2020
11	NDC: 74146-236-53	3550 mL in 1 JUG; Type 0: Not a Combination Product
12	NDC: 74146-236-56	4 in 1 BOX	05/18/2020
12	NDC: 74146-236-55	3550 mL in 1 JUG; Type 0: Not a Combination Product
13	NDC: 74146-236-58	4 in 1 BOX	05/18/2020
13	NDC: 74146-236-57	2500 mL in 1 JUG; Type 0: Not a Combination Product
14	NDC: 74146-236-60	4 in 1 BOX	05/18/2020
14	NDC: 74146-236-59	2500 mL in 1 JUG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/18/2020

Labeler - GM Industrial, Inc. (025827197)

Registrant - GM Industrial, Inc. (025827197)

Establishment
Name	Address	ID/FEI	Business Operations
GM Industrial, Inc.		025827197	manufacture(74146-234, 74146-236) , label(74146-234, 74146-236) , pack(74146-234, 74146-236)