Antibacterial

Manufacturer: Henry Schein, Inc. | Safetec of America, Inc.
Effective date: 2025-01-10
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 00:51:46

Label at a glance#

ProductAntibacterial

Active ingredientCHLOROXYLENOL

Label structure8 sections

Indications and uses

For handwashing to decrease bacteria on skin. Recommended for repeated use.

Dosage and administration

Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 30 seconds. Rinse and repeat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol (PCMX) 0.6%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on skin. Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

supervise children under 6
do not use in the eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask doctor ifirritation or redness develop and persist for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 30 seconds. Rinse and repeat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, cocamide DEA, cocamidopropyl betaine, fragrance, germaben II, propylene glycol, purified water, sodium chloride, sodium laureth sulfate, tetrasodium EDTA, vitamin E acetate

PRINCIPAL DISPLAY PANEL – 550 mL (18.6 fl. oz.) bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Henry Schein

Antibacterial

HAND SOAP

Spring Water

Jabón de manos
antibacteriano

Savon antibactérien
pour les mains

Foaming

18.6 fl. oz. • 550 ml

PRINCIPAL DISPLAY PANEL – 550 mL (18.6 fl. oz.) bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
413262	chloroxylenol 0.6 % Medicated Liquid Soap	PSN	7
413262	chloroxylenol 6 MG/ML Medicated Liquid Soap	SCD	7
413262	chloroxylenol 0.6 % Medicated Liquid Soap	SY	7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-4441-01	Antibacterial	0.55 L in 1 BOTTLE	LIQUID	0.55		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-4441	ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [HENRY SCHEIN, INC.]	7	Current NDC, Legacy NDC, 1 package rows	20250112_22a162f7-4408-47c1-a792-a6fbdabdb331.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
chloroxylenol	ACTIVE INGREDIENT	0F32U78V2Q	1
chloroxylenol	ACTIVE MOIETY	0F32U78V2Q	1
.alpha.-tocopherol acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
aloe vera leaf	INACTIVE INGREDIENT	ZY81Z83H0X	1
cocamidopropyl betaine	INACTIVE INGREDIENT	5OCF3O11KX	1
coco diethanolamide	INACTIVE INGREDIENT	92005F972D	1
diazolidinyl urea	INACTIVE INGREDIENT	H5RIZ3MPW4	1
edetate sodium	INACTIVE INGREDIENT	MP1J8420LU	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	1
sodium laureth-3 sulfate	INACTIVE INGREDIENT	BPV390UAP0	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Antibacterial
chloroxylenol
ALOE VERA LEAF
COCO DIETHANOLAMIDE
COCAMIDOPROPYL BETAINE
PROPYLENE GLYCOL
WATER
EDETATE SODIUM
.ALPHA.-TOCOPHEROL ACETATE
DMDM HYDANTOIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0404-4441	0404-4441-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALOE VERA LEAF	ZY81Z83H0X	IACT
COCO DIETHANOLAMIDE	92005F972D	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
EDETATE SODIUM	MP1J8420LU	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
CHLOROXYLENOL	0F32U78V2Q	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 114 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
edetate sodium	EDETATE SODIUM	MP1J8420LU	SPONGE / TOPICAL	0.14 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
edetate sodium	EDETATE SODIUM	MP1J8420LU	SHAMPOO / TOPICAL	1.33 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii+route 30 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii+route 46 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAVENOUS		6320 mg	Exact identifier — unii+dosage form 30 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii+route 46 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / TOPICAL	3.1 mg		Exact identifier — unii+route 30 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii+route 46 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii+route 46 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii+route 46 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii+route 46 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	LIQUID / NASAL	7.4 mg/1ml		Exact identifier — unii+dosage form 30 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	LIQUID / SUBCUTANEOUS	0.7 %w/v		Exact identifier — unii+dosage form 30 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
coco diethanolamide	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii+route 46 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route 46 equally ranked IID candidates
coco diethanolamide	COCO DIETHANOLAMIDE	92005F972D	SUSPENSION / TOPICAL	4 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii+route 46 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	GEL / TOPICAL	0.18 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
coco diethanolamide	COCO DIETHANOLAMIDE	92005F972D	CREAM / TOPICAL		30 mg	Exact identifier — unii+route 10 equally ranked IID candidates
edetate sodium	EDETATE SODIUM	MP1J8420LU	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii+route 46 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+dosage form 46 equally ranked IID candidates
edetate sodium	EDETATE SODIUM	MP1J8420LU	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / TOPICAL	3.1 mg		Exact identifier — unii+route 30 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii+dosage form 46 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii+route 46 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii+route 6 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
coco diethanolamide	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
coco diethanolamide	COCO DIETHANOLAMIDE	92005F972D	SHAMPOO / TOPICAL		600 mg	Exact identifier — unii+route 10 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / TOPICAL	0.23 %w/v		Exact identifier — unii+route 30 equally ranked IID candidates
edetate sodium	EDETATE SODIUM	MP1J8420LU	LOTION / TOPICAL	0.17 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii+route 30 equally ranked IID candidates
coco diethanolamide	COCO DIETHANOLAMIDE	92005F972D	CREAM / TOPICAL		30 mg	Exact identifier — unii+route 10 equally ranked IID candidates
edetate sodium	EDETATE SODIUM	MP1J8420LU	SHAMPOO / TOPICAL	1.33 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
sodium laureth-3 sulfate	SODIUM LAURETH-3 SULFATE	BPV390UAP0	SHAMPOO / TOPICAL		3192 mg	Exact identifier — unii+route 6 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii+route 46 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii+route 46 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+dosage form 46 equally ranked IID candidates
coco diethanolamide	COCO DIETHANOLAMIDE	92005F972D	SHAMPOO / TOPICAL		600 mg	Exact identifier — unii+route 10 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii+route 46 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii+route 46 equally ranked IID candidates
sodium laureth-3 sulfate	SODIUM LAURETH-3 SULFATE	BPV390UAP0	SPRAY / TOPICAL	0.1 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii+route 30 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / TOPICAL	0.23 %w/v		Exact identifier — unii+route 30 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii+route 46 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAVENOUS		6320 mg	Exact identifier — unii+dosage form 30 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii+route 46 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii+route 46 equally ranked IID candidates
edetate sodium	EDETATE SODIUM	MP1J8420LU	SOAP / TOPICAL	0.12 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antibacterial	CHLOROXYLENOL	Henry Schein, Inc.	22a162f7-4408-47c1-a792-a6fbdabdb331	2025-01-10	Warnings	Exact identifier ndc (package): 0404-4441-01 ndc (product): 0404-4441 ndc11 (package): 00404444101 spl id: 2b5c5b12-5a09-b779-e063-6394a90a5238 spl set id: 22a162f7-4408-47c1-a792-a6fbdabdb331

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.