POWERHOUSE ULTRA DISH ANTIBACTERIAL- chloroxylenol liquid 
Delta Brands & Products LLC

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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Drug Facts

Active ingredient

Chloroxylenol 0.30%

Purpose

Antibacterial

Use

for handwashing to decrease bacteria on the skin

Warnings

For external use only: hands only

When using this product

■ do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

■ irritation and redness develops ■ 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

■ wet hands ■ apply palmful to hands ■ scrub thoroughly ■ rinse thoroughly

Inactive ingredients

Water (Aqua), Sodium Laureth Sulfate, Lauramine Oxide,Sodium Lauryl Sulfate, Alcohol Denat. Sodium Chloride, Tetrasodium EDTA, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5, Red 40

Package Label

Package Label

POWERHOUSE  ULTRA DISH ANTIBACTERIAL
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72133-152
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
ALCOHOL (UNII: 3K9958V90M)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72133-152-25740 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/16/2018
Labeler - Delta Brands & Products LLC (080999173)

Revised: 4/2018
Document Id: 6a3928d3-d181-519b-e053-2991aa0acb81
Set id: 6a3928d3-d17e-519b-e053-2991aa0acb81
Version: 1
Effective Time: 20180419
 
Delta Brands & Products LLC