EZ FOAM 6793- triclosan soap 
OSCEOLA SUPPLY, 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.

----------

EZ Foam 6793 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

EZ Foam 6793 1000mL

image of bag label

image of bag labelimage of bag labelEZ Foam 6793 1000mL

EZ FOAM 6793 
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62672-793
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:62672-793-061 in 1 BOX04/18/2017
1800 mL in 1 BAG; Type 0: Not a Combination Product
2NDC:62672-793-081 in 1 BOX04/18/2017
21000 mL in 1 BAG; Type 0: Not a Combination Product
3NDC:62672-793-17532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/18/2017
4NDC:62672-793-24118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/18/2017
5NDC:62672-793-011200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product04/18/2017
6NDC:62672-793-03350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product04/18/2017
7NDC:62672-793-05540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/18/2017
8NDC:62672-793-07700 mL in 1 BAG; Type 0: Not a Combination Product04/18/2017
9NDC:62672-793-092000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product04/18/2017
10NDC:62672-793-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product04/18/2017
11NDC:62672-793-111000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/18/2017
12NDC:62672-793-121000 mL in 1 BAG; Type 0: Not a Combination Product04/18/2017
13NDC:62672-793-13800 mL in 1 BAG; Type 0: Not a Combination Product04/18/2017
14NDC:62672-793-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/18/2017
15NDC:62672-793-15946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/18/2017
16NDC:62672-793-28149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/18/2017
17NDC:62672-793-27800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product04/18/2017
18NDC:62672-793-55208200 mL in 1 DRUM; Type 0: Not a Combination Product04/18/2017
19NDC:62672-793-16236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/18/2017
20NDC:62672-793-1850 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/18/2017
21NDC:62672-793-31750 mL in 1 BAG; Type 0: Not a Combination Product04/18/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/18/2017
Labeler - OSCEOLA SUPPLY, INC. (809050479)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(62672-793)

Revised: 4/2017
Document Id: 2cf75cf0-4bdb-4ff1-aa11-86e69c84dd7e
Set id: 5d0f8666-5a9c-4f58-b1d4-4f59ab2c868d
Version: 1
Effective Time: 20170418
 
OSCEOLA SUPPLY, INC.