PURGO ULTRA PC - chloroxylenol soap 
Certus Medical, 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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Purgo Ultra PC 6176 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Chloroxylenol 0.6%


Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on  the skin

Drug Facts Box OTC-Warnings Section

For external use only

Drug Facts Box OTC-When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

irritation and redness develop

Drug Facts Box OTC-Keep Out of Reach of Children Section

if swallowed, get medical help or contact a Poison Control Center right away

Drug Facts Box OTC-Dosage & Administration Section

wet hands and forearms

apply 5 milliliters (teaspoonful) or palmful to hands and forearms

scrub thoroughly for 1 minute and rinse

Drug Facts Box OTC-Inactive Ingredient Section

water, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, propylene glycol, sodium chloride, PEG-75 lanolin, sodium styrene/PEG-10 maleate/nonoxynol-10 maleate/acrylates copolymer, boric acid, fragrance, methylparaben, propylparaben, aloe barbadensis

Purgo Ultra PC 6176 1000ml

6176M5PM.jpg  Purgo Ultra PC  1000ml  image of bag label

PURGO ULTRA PC 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75990-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BORIC ACID (UNII: R57ZHV85D4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75990-300-061 in 1 BOX
1800 mL in 1 BAG
2NDC:75990-300-17532 mL in 1 BOTTLE, PLASTIC
3NDC:75990-300-24118 mL in 1 BOTTLE, PLASTIC
4NDC:75990-300-011200 mL in 1 CARTRIDGE
5NDC:75990-300-03350 mL in 1 CARTRIDGE
6NDC:75990-300-05540 mL in 1 BOTTLE, PLASTIC
7NDC:75990-300-07700 mL in 1 BAG
8NDC:75990-300-092000 mL in 1 CARTRIDGE
9NDC:75990-300-101000 mL in 1 CARTRIDGE
10NDC:75990-300-111000 mL in 1 BOTTLE, PLASTIC
11NDC:75990-300-121000 mL in 1 BAG
12NDC:75990-300-13800 mL in 1 BAG
13NDC:75990-300-143785 mL in 1 BOTTLE, PLASTIC
14NDC:75990-300-15946 mL in 1 BOTTLE, PLASTIC
15NDC:75990-300-28149 mL in 1 BOTTLE, PLASTIC
16NDC:75990-300-27800 mL in 1 CARTRIDGE
17NDC:75990-300-552082 mL in 1 DRUM
18NDC:75990-300-081 in 1 BOX
181000 mL in 1 BAG
19NDC:75990-300-16236 mL in 1 BOTTLE, PLASTIC
20NDC:75990-300-1850 mL in 1 BOTTLE, PLASTIC
21NDC:75990-300-191890 mL in 1 CONTAINER
22NDC:75990-300-207560 mL in 1 DRUM
23NDC:75990-300-351325 mL in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/25/2011
Labeler - Certus Medical, Inc. (966433653)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture

Revised: 4/2011
Document Id: 25e7f9a9-a63b-4f71-8fa5-547e80d08c8a
Set id: c0f23c3e-809b-498e-8828-4dd94653db58
Version: 1
Effective Time: 20110425
 
Certus Medical, Inc.