1014 FOAMING ANTIMICROBIAL- triclosan soap

1014 Foaming Antimicrobial by

Drug Labeling and Warnings

1014 Foaming Antimicrobial by is a Otc medication manufactured, distributed, or labeled by ABC Compounding Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

1014 FOAMING ANTIMICROBIAL  
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62257-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.003 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62257-014-06	1 in 1 BOX
1		800 mL in 1 BAG
2	NDC: 62257-014-17	532 mL in 1 BOTTLE, PLASTIC
3	NDC: 62257-014-24	118 mL in 1 BOTTLE, PLASTIC
4	NDC: 62257-014-01	1200 mL in 1 CARTRIDGE
5	NDC: 62257-014-03	350 mL in 1 CARTRIDGE
6	NDC: 62257-014-05	540 mL in 1 BOTTLE, PLASTIC
7	NDC: 62257-014-07	700 mL in 1 BAG
8	NDC: 62257-014-09	2000 mL in 1 CARTRIDGE
9	NDC: 62257-014-10	1000 mL in 1 CARTRIDGE
10	NDC: 62257-014-11	1000 mL in 1 BOTTLE, PLASTIC
11	NDC: 62257-014-12	1000 mL in 1 BAG
12	NDC: 62257-014-13	800 mL in 1 BAG
13	NDC: 62257-014-14	3785 mL in 1 BOTTLE, PLASTIC
14	NDC: 62257-014-15	946 mL in 1 BOTTLE, PLASTIC
15	NDC: 62257-014-28	149 mL in 1 BOTTLE, PLASTIC
16	NDC: 62257-014-27	800 mL in 1 CARTRIDGE
17	NDC: 62257-014-55	208200 mL in 1 DRUM
18	NDC: 62257-014-08	1 in 1 BOX
18		1000 mL in 1 BAG
19	NDC: 62257-014-16	236 mL in 1 BOTTLE, PLASTIC
20	NDC: 62257-014-18	50 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2013

Labeler - ABC Compounding Co., Inc. (003284353)

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture(62257-014)