EPIC- chloroxylenol 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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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 NDC: 74146-237-79

2.5 L PDP ZENEX EPIC

2.5 L NDC: 74146-237-772.5 L pdp 74146-237-77

3.5 L PDP CHEM EPIC

3.5 L 74146-237-75 3.55 L NDC: 74146-237-75

3.5 L PDP ZENEX EPIC

3.55 L 74146-237-73 3.55 L NDC: 74146-237-73

EPIC 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74146-237
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74146-237-804 in 1 BOX06/09/2023
1NDC:74146-237-792500 mL in 1 JUG; Type 0: Not a Combination Product
2NDC:74146-237-644 in 1 BOX06/09/2023
2NDC:74146-237-633785.41 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/09/2023
Labeler - GM Industrial, Inc. (025827197)
Establishment
NameAddressID/FEIBusiness Operations
GM Industrial, Inc.025827197manufacture(74146-237) , pack(74146-237) , label(74146-237) , repack(74146-237) , relabel(74146-237)

Revised: 6/2021
Document Id: c457405f-24ce-2e28-e053-2995a90abef4
Set id: c456b212-1065-8a16-e053-2995a90aebc9
Version: 2
Effective Time: 20210609
 
GM Industrial, Inc.