DailyMed - SURGENT ANTISEPTIC- chloroxylenol soap

NDC Code(s): 66155-544-01, 66155-544-03, 66155-544-05, 66155-544-06, view more
66155-544-07, 66155-544-08, 66155-544-09, 66155-544-10, 66155-544-11, 66155-544-12, 66155-544-13, 66155-544-14, 66155-544-15, 66155-544-16, 66155-544-17, 66155-544-18, 66155-544-19, 66155-544-20, 66155-544-24, 66155-544-27, 66155-544-28, 66155-544-35, 66155-544-55
Packager: SunCoast Paper Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated April 22, 2025

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Drug Facts Box OTC-Active Ingredient Section
Chloroxylenol 0.3%

Chloroxylenol 0.3%

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Drug Facts Box OTC-Purpose Section
Antiseptic

Antiseptic
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Drug Facts Box OTC-Indications & Usage Section
for hand-washing to decrease bacteria on the skin

for hand-washing to decrease bacteria on the skin

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Drug Facts Box OTC-Warnings Section
For external use only

For external use only
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Drug Facts Box OTC-When Using Section
do not get into eyes - if contact occurs, rinse eyes thoroughly with water

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

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Drug Facts Box OTC-Stop Use Section
irritation and redness develop

irritation and redness develop

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Drug Facts Box OTC-Keep Out of Reach of Children Section
if swallowed, get medical help or contact a Poison Control Center right away

if swallowed, get medical help or contact a Poison Control Center right away

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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
- wet hands and forearms
- apply 5 milliliters (teaspoonful) or palmful to hands and forearms
- scrub thoroughly for 1 minute and rinse
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Drug Facts Box OTC-Inactive Ingredient Section
water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, sodium chloride, citric acid, DMDM hydantoin, fragrance, FD and C yellow no.5, food red 10

water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, sodium chloride, citric acid, DMDM hydantoin, fragrance, FD and C yellow no.5, food red 10
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Surgent Antiseptic Hand Soap 800 mL
Surgent Antiseptic Hand Soap 800 mL

Surgent Antiseptic Hand Soap 800 mL
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INGREDIENTS AND APPEARANCE

Product Information

SURGENT ANTISEPTIC chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66155-544
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)
DMDM HYDANTOIN (UNII: BYR0546TOW)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:66155-544-06	1 in 1 BOX	10/12/2015
1		800 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC:66155-544-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2015
3	NDC:66155-544-24	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2015
4	NDC:66155-544-01	1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	10/12/2015
5	NDC:66155-544-03	350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	10/12/2015
6	NDC:66155-544-05	540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2015
7	NDC:66155-544-07	700 mL in 1 BAG; Type 0: Not a Combination Product	10/12/2015
8	NDC:66155-544-09	2000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	10/12/2015
9	NDC:66155-544-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	10/12/2015
10	NDC:66155-544-11	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2015
11	NDC:66155-544-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	10/12/2015
12	NDC:66155-544-13	800 mL in 1 BAG; Type 0: Not a Combination Product	10/12/2015
13	NDC:66155-544-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2015
14	NDC:66155-544-15	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2015
15	NDC:66155-544-28	149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2015
16	NDC:66155-544-27	800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	10/12/2015
17	NDC:66155-544-55	208200 mL in 1 DRUM; Type 0: Not a Combination Product	10/12/2015
18	NDC:66155-544-08	1 in 1 BOX	10/12/2015
18		1000 mL in 1 BAG; Type 0: Not a Combination Product
19	NDC:66155-544-16	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2015
20	NDC:66155-544-18	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2015
21	NDC:66155-544-19	18900 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/12/2015
22	NDC:66155-544-20	75600 mL in 1 DRUM; Type 0: Not a Combination Product	10/12/2015
23	NDC:66155-544-35	132500 mL in 1 DRUM; Type 0: Not a Combination Product	10/12/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M003	03/01/2012

Labeler - SunCoast Paper Inc. (031211089)

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

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(66155-544)

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Published Date (What is this?)	Version	Files
Apr 24, 2025	3 (current)	download
Dec 28, 2018	2	download
Jul 7, 2016	1	download

	RxCUI	RxNorm NAME	RxTTY
1	413261	chloroxylenol 0.3 % Medicated Liquid Soap	PSN
2	413261	chloroxylenol 3 MG/ML Medicated Liquid Soap	SCD
3	413261	chloroxylenol 0.3 % Medicated Liquid Soap	SY

Label: SURGENT ANTISEPTIC- chloroxylenol soap

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	NDC
1	66155-544-01
2	66155-544-03
3	66155-544-05
4	66155-544-06
5	66155-544-07
6	66155-544-08
7	66155-544-09
8	66155-544-10
9	66155-544-11
10	66155-544-12
11	66155-544-13
12	66155-544-14
13	66155-544-15
14	66155-544-16
15	66155-544-17
16	66155-544-18
17	66155-544-19
18	66155-544-20
19	66155-544-24
20	66155-544-27
21	66155-544-28
22	66155-544-35
23	66155-544-55

Label: SURGENT ANTISEPTIC- chloroxylenol soap

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Drug Label Info

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SURGENT ANTISEPTIC- chloroxylenol soap

Number of versions: 3

SURGENT ANTISEPTIC- chloroxylenol soap

SURGENT ANTISEPTIC- chloroxylenol soap

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SURGENT ANTISEPTIC- chloroxylenol soap

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.