EPIC- chloroxylenol 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?)

Chloroxylenol 0.3%

Antiseptic

Uses

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

Warnings

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, Propylene Glycol, Cocamidopropyl Betaine, Sodium Laureth Sulfate, Sodium Chloride, Glycerin, Magnesium Nitrate, Methylchloroisothiazolinone, Methylisothiazolinone.

2.5 L PDP CHEM EPIC

2.5 L pdp 74146-237-79

2.5 L PDP ZENEX EPIC

2.5 L pdp 74146-237-77

3.5 L PDP CHEM EPIC

3.5 L 74146-237-75

3.5 L PDP ZENEX EPIC

3.55 L 74146-237-73

INGREDIENTS AND APPEARANCE

EPIC 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74146-237
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74146-237-80	4 in 1 BOX	06/09/2023
1	NDC: 74146-237-79	2500 mL in 1 JUG; Type 0: Not a Combination Product
2	NDC: 74146-237-64	4 in 1 BOX	06/09/2023
2	NDC: 74146-237-63	3785.41 mL in 1 CONTAINER; 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	06/09/2023

Labeler - GM Industrial, Inc. (025827197)

Establishment
Name	Address	ID/FEI	Business Operations
GM Industrial, Inc.		025827197	manufacture(74146-237) , pack(74146-237) , label(74146-237) , repack(74146-237) , relabel(74146-237)