1014 FOAMING ANTIMICROBIAL  - triclosan soap 
ABC Compounding Co., 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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1014 Foaming Antimicrobial 6576 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, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, alcohol denat., propylene glycol, tetrasodium EDTA, PEG-75 lanolin,  boric acid, lauramine oxide, chloroxylenol, methylparaben, propylparaben, fragrance, aloe barbadensis, acid red 1, reactive green 12

1014 Foaming Antimicrobial 6576 1 gallon bottle

657641PSP.jpg  1014 Foaming Antimicrobial 1 gallon bottle image of bottle label

1014 FOAMING ANTIMICROBIAL  
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62257-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.003 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
BORIC ACID (UNII: R57ZHV85D4)  
ALCOHOL (UNII: 3K9958V90M)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62257-014-061 in 1 BOX
1800 mL in 1 BAG
2NDC:62257-014-17532 mL in 1 BOTTLE, PLASTIC
3NDC:62257-014-24118 mL in 1 BOTTLE, PLASTIC
4NDC:62257-014-011200 mL in 1 CARTRIDGE
5NDC:62257-014-03350 mL in 1 CARTRIDGE
6NDC:62257-014-05540 mL in 1 BOTTLE, PLASTIC
7NDC:62257-014-07700 mL in 1 BAG
8NDC:62257-014-092000 mL in 1 CARTRIDGE
9NDC:62257-014-101000 mL in 1 CARTRIDGE
10NDC:62257-014-111000 mL in 1 BOTTLE, PLASTIC
11NDC:62257-014-121000 mL in 1 BAG
12NDC:62257-014-13800 mL in 1 BAG
13NDC:62257-014-143785 mL in 1 BOTTLE, PLASTIC
14NDC:62257-014-15946 mL in 1 BOTTLE, PLASTIC
15NDC:62257-014-28149 mL in 1 BOTTLE, PLASTIC
16NDC:62257-014-27800 mL in 1 CARTRIDGE
17NDC:62257-014-55208200 mL in 1 DRUM
18NDC:62257-014-081 in 1 BOX
181000 mL in 1 BAG
19NDC:62257-014-16236 mL in 1 BOTTLE, PLASTIC
20NDC:62257-014-1850 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/2013
Labeler - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(62257-014)

Revised: 5/2013
Document Id: e3f8a26b-2a48-45ee-9557-0cc750634a5d
Set id: 544e7139-a7e6-41dc-9af6-30e8b501ca2e
Version: 1
Effective Time: 20130501
 
ABC Compounding Co., Inc.