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 MIPA, propylene glycol, sodium chloride, citric acid, fragrance, FD and C yellow no.5, food red 10

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 Item Code (Source) NDC:62257-012
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 3 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
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 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(62257-012)

Revised: 3/2014
Document Id: 53e30cc3-4653-427c-9564-a2b89b381a0f
Set id: 4dc6367c-5347-4a5c-b0d0-e93a4277a849
Version: 2
Effective Time: 20140327
 
ABC Compounding Co., Inc.