PURGO SATIN 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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6793 Purgo Satin Foam 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 red 4, acid red 1

6793 Purgo Satin Foam Drug Facts and Label

6793 Purgo Satin Foam Drug Facts and Label    6793 product label6793 product label

PURGO SATIN FOAM 
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75990-793
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)  
MONOETHANOLAMINE (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 RED NO. 4 (UNII: X3W0AM1JLX)  
DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75990-793-061 in 1 BOX12/15/2017
1800 mL in 1 BAG; Type 0: Not a Combination Product
2NDC:75990-793-081 in 1 BOX12/15/2017
21000 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/15/2017
Labeler - Certus Medical, Inc. (966433653)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(75990-793)

Revised: 12/2017
Document Id: b48fcfce-3dfb-451e-86cd-975688dd9aea
Set id: 67317668-57f7-4602-90ff-c5a3ba8983f1
Version: 4
Effective Time: 20171218
 
Certus Medical, Inc.