1012 ANTIMICROBIAL - chloroxylenol 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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1012 Antimicrobial 6544 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Chloroxylenol 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, decyl glucoside, sodium laureth sulfate, cocamide DEA, propylene glycol, sodium chloride, citric acid, fragrance, hexahydro-1,3,5-tris(2-hydroxyethyl)-s-triazine, acid yellow 36, acid red 1

1012 Antimicrobial 6544 1 gallon bottle

654441PSP.jpg 1012 Antimicrobial 1 gallon bottle image of bottle label

1012 ANTIMICROBIAL
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:62257-012
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (CHLOROXYLENOL)	CHLOROXYLENOL	0.003 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER
PROPYLENE GLYCOL
SODIUM LAURETH SULFATE
CITRIC ACID MONOHYDRATE
METANIL YELLOW
SODIUM CHLORIDE

#	Item Code	Package Description
Packaging
1	NDC:62257-012-06	1 in 1 BOX
1		800 mL in 1 BAG
2	NDC:62257-012-17	532 mL in 1 BOTTLE, PLASTIC
3	NDC:62257-012-24	118 mL in 1 BOTTLE, PLASTIC
4	NDC:62257-012-01	1200 mL in 1 CARTRIDGE
5	NDC:62257-012-03	350 mL in 1 CARTRIDGE
6	NDC:62257-012-05	540 mL in 1 BOTTLE, PLASTIC
7	NDC:62257-012-07	700 mL in 1 BAG
8	NDC:62257-012-09	2000 mL in 1 CARTRIDGE
9	NDC:62257-012-10	1000 mL in 1 CARTRIDGE
10	NDC:62257-012-11	1000 mL in 1 BOTTLE, PLASTIC
11	NDC:62257-012-12	1000 mL in 1 BAG
12	NDC:62257-012-13	800 mL in 1 BAG
13	NDC:62257-012-14	3785 mL in 1 BOTTLE, PLASTIC
14	NDC:62257-012-15	946 mL in 1 BOTTLE, PLASTIC
15	NDC:62257-012-28	149 mL in 1 BOTTLE, PLASTIC
16	NDC:62257-012-27	800 mL in 1 CARTRIDGE
17	NDC:62257-012-55	208200 mL in 1 DRUM
18	NDC:62257-012-08	1 in 1 BOX
18		1000 mL in 1 BAG
19	NDC:62257-012-16	236 mL in 1 BOTTLE, PLASTIC
20	NDC:62257-012-18	50 mL in 1 BOTTLE, PLASTIC
21	NDC:62257-012-19	18900 mL in 1 CONTAINER
22	NDC:62257-012-20	75600 mL in 1 DRUM
23	NDC:62257-012-35	132500 mL in 1 DRUM

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

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

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(62257-012)

Revised: 5/2013

Document Id: 8b0ed3f8-11d0-42c9-981d-4964af104eed

Set id: 4dc6367c-5347-4a5c-b0d0-e93a4277a849

Version: 1

Effective Time: 20130501

ABC Compounding Co., Inc.