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Antibacterial

ABC Compounding Co., Inc.

Antibacterial 6544 Drug Facts and Label


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Antibacterial 1200 ml

6544N3PA.jpg  Antibacterial 1200 ml  Antibacterial

Antibacterial

CHLOROXYLENOL SOAP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62257-770
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chloroxylenol Chloroxylenol 3 mg

Inactive Ingredients

Ingredient Name Strength
water
propylene glycol
SODIUM LAURETH SULFATE
CITRIC ACID MONOHYDRATE
DECYL GLUCOSIDE
SODIUM CHLORIDE
COCO MONOISOPROPANOLAMIDE
FD&C YELLOW NO. 5

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 800 in 1 BAG
2 NDC:62257-770-17 532 in 1 BOTTLE, PLASTIC
3 NDC:62257-770-24 118 in 1 BOTTLE, PLASTIC
4 NDC:62257-770-01 1200 in 1 CARTRIDGE
5 NDC:62257-770-03 350 in 1 CARTRIDGE
6 NDC:62257-770-05 540 in 1 BOTTLE, PLASTIC
7 NDC:62257-770-07 700 in 1 BAG
8 NDC:62257-770-09 2000 in 1 CARTRIDGE
9 NDC:62257-770-10 1000 in 1 CARTRIDGE
10 NDC:62257-770-11 1000 in 1 BOTTLE, PLASTIC
11 NDC:62257-770-12 1000 in 1 BAG
12 NDC:62257-770-13 800 in 1 BAG
13 NDC:62257-770-14 3785 in 1 BOTTLE, PLASTIC
14 NDC:62257-770-15 946 in 1 BOTTLE, PLASTIC
15 NDC:62257-770-28 149 in 1 BOTTLE, PLASTIC
16 NDC:62257-770-27 800 in 1 CARTRIDGE
17 NDC:62257-770-55 208200 in 1 DRUM
18 1000 in 1 BAG
19 NDC:62257-770-16 236 in 1 BOTTLE, PLASTIC
20 NDC:62257-770-18 50 in 1 BOTTLE, PLASTIC
21 NDC:62257-770-19 18900 in 1 CONTAINER
22 NDC:62257-770-20 75600 in 1 DRUM
23 NDC:62257-770-35 132500 in 1 DRUM

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partE part333E 2014-04-09


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