PURGO ULTRA FOAM - triclosan 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 Foam 6954 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Triclosan 0.3%

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, propylene glycol, alcohol denat., disodium cocoamphodipropionate, lauric acid, ethanolamine, lactic acid, isopropyl alcohol, tetrasodium EDTA, polyquaternium 10,  PEG-4, fragrance, methylparaben, propylparaben, FDC blue 1, FDC green 8, FDC orange 4

Purgo Ultra Foam 6954 1000ml

6954M5PM.jpg  Purgo Ultra Foam  1000ml  image of bag label

PURGO ULTRA FOAM 
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75990-576
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3.0 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALCOHOL (UNII: 3K9958V90M)  
LAURIC ACID (UNII: 1160N9NU9U)  
ETHANOLAMINE (UNII: 5KV86114PT)  
LACTIC ACID (UNII: 33X04XA5AT)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
EDETATE SODIUM (UNII: MP1J8420LU)  
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C GREEN NO. 8 (UNII: I2W85YOX9L)  
D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75990-576-061 in 1 BOX
1800 mL in 1 BAG
2NDC:75990-576-081 in 1 BOX
21000 mL in 1 BAG
3NDC:75990-576-17532 mL in 1 BOTTLE, PLASTIC
4NDC:75990-576-24118 mL in 1 BOTTLE, PLASTIC
5NDC:75990-576-011200 mL in 1 CARTRIDGE
6NDC:75990-576-03350 mL in 1 CARTRIDGE
7NDC:75990-576-05540 mL in 1 BOTTLE, PLASTIC
8NDC:75990-576-07700 mL in 1 BAG
9NDC:75990-576-092000 mL in 1 CARTRIDGE
10NDC:75990-576-101000 mL in 1 CARTRIDGE
11NDC:75990-576-111000 mL in 1 BOTTLE, PLASTIC
12NDC:75990-576-121000 mL in 1 BAG
13NDC:75990-576-13800 mL in 1 BAG
14NDC:75990-576-143785 mL in 1 BOTTLE, PLASTIC
15NDC:75990-576-15946 mL in 1 BOTTLE, PLASTIC
16NDC:75990-576-28149 mL in 1 BOTTLE, PLASTIC
17NDC:75990-576-27800 mL in 1 CARTRIDGE
18NDC:75990-576-55208200 mL in 1 DRUM
19NDC:75990-576-16236 mL in 1 BOTTLE, PLASTIC
20NDC:75990-576-1850 mL in 1 BOTTLE, PLASTIC
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: 3/2012
Document Id: 66918764-8f63-46db-8d27-0e41cd1c86ea
Set id: ed78beeb-6928-46e1-a3f3-ce10e8f20bf4
Version: 2
Effective Time: 20120301
 
Certus Medical, Inc.