TRICLOSAN

Manufacturer: Columbia Jobbing | Canberra Corporation
Effective date: 2012-09-12
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:33:05

Label at a glance#

ProductTRICLOSAN

Active ingredientTRICLOSAN

Label structure9 sections

Indications and uses

Handwash to help reduce bacteria that potentially can cause disease. Recommended for repeated use.

Dosage and administration

Wet hands and forearms Apply appropriate amount to hands and forearms Scrub hands and forearms thoroughly for 60 seconds Use scrub and/or nail brush to aid in cleaning. Rinse well Wipe dry with towel, repeat as necessary.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Triclosan (0.35%)

Purpose:

OTC - PURPOSE SECTION

Antiseptic Hand Cleanser

Uses

INDICATIONS & USAGE SECTION

Handwash to help reduce bacteria that potentially can cause disease.
Recommended for repeated use.

Warning

WARNINGS SECTION

For external use only
Do not use near eyes

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Discontinue use if irritation and redness develop. If condition persists more than 72 hours, consult a doctor.

In case of eye contact, flush with water for 15 minutes. If irritation persists, get medical attention. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands and forearms
Apply appropriate amount to hands and forearms
Scrub hands and forearms thoroughly for 60 seconds
Use scrub and/or nail brush to aid in cleaning.
Rinse well
Wipe dry with towel, repeat as necessary.

Other Information

SPL UNCLASSIFIED SECTION

Assists with OSHA bloodborne pathogen standard compliance

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Propylene Glycol, Lauramide DEA, Cocamide DEA, Cocamidopropyl betaine, Sodium Cumene Sulfonate, Citric Acid, Fragrance, DMDM Hydantoin, Sodium Chloride, FD&C Green #3.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

Bio CLEAN

Foaming Antiseptic Hand Cleaner

A powerful antiseptic cleanser for handwashing

Enhanced with moisturizers
Reduces bacteria on skin that can potentially cause disease
Assists with OSHA bloodborne pathogen standard compliance

KEEP OUT OF REACH OF CHILDREN

CAUTION

See Drug Facts for panel for additional information.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53119-575-20	2019-11-13	C162847	48780-1	97449f38-cbb7-f6ea-e053-dbdaa90aa703	7c149887-b375-46d4-ac78-4f838464111e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53119-575-20	TRICLOSAN	1100 mL in 1 BOTTLE	LIQUID	1100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53119-575	TRICLOSAN LIQUID [COLUMBIA JOBBING]	2	Legacy NDC, 1 package rows	20120921_7c149887-b375-46d4-ac78-4f838464111e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TRICLOSAN	ACTIVE INGREDIENT	4NM5039Y5X	2
TRICLOSAN	ACTIVE MOIETY	4NM5039Y5X	2
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	2
cocamidopropyl betaine	INACTIVE INGREDIENT	5OCF3O11KX	2
coco diethanolamide	INACTIVE INGREDIENT	92005F972D	2
dmdm hydantoin	INACTIVE INGREDIENT	BYR0546TOW	2
FD&C Green NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	2
lauric diethanolamide	INACTIVE INGREDIENT	I29I2VHG38	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	2
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	2
sodium laureth sulfate	INACTIVE INGREDIENT	BPV390UAP0	2
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	2
water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

TRICLOSAN
water
sodium laureth sulfate
sodium lauryl sulfate
propylene glycol
lauric diethanolamide
cocamidopropyl betaine
coco diethanolamide
citric acid monohydrate
dmdm hydantoin
sodium chloride
FD&C Green NO. 3

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53119-575	53119-575-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TRICLOSAN	4NM5039Y5X	ACTIB
water	059QF0KO0R	IACT
sodium laureth sulfate	BPV390UAP0	IACT
sodium lauryl sulfate	368GB5141J	IACT
propylene glycol	6DC9Q167V3	IACT
lauric diethanolamide	I29I2VHG38	IACT
cocamidopropyl betaine	5OCF3O11KX	IACT
coco diethanolamide	92005F972D	IACT
citric acid monohydrate	2968PHW8QP	IACT
dmdm hydantoin	BYR0546TOW	IACT
sodium chloride	451W47IQ8X	IACT
FD&C Green NO. 3	3P3ONR6O1S	IACT

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 7 · 377 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	DROPS / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EXTENDED RELEASE / ORAL		45 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / IONTOPHORESIS	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
coco diethanolamide	COCO DIETHANOLAMIDE	92005F972D	SHAMPOO / TOPICAL		600 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	GEL / VAGINAL	0.2 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	SPRAY / TOPICAL		7 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / OPHTHALMIC		13 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	CONCENTRATE / ORAL	5.3 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION, EXTENDED RELEASE / ORAL	140.8 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	GEL / TOPICAL	0.18 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAOCULAR		320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM, EXTENDED RELEASE / TRANSDERMAL	1.38 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRATHECAL		131 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / SUBLINGUAL		24 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUPPOSITORY / VAGINAL	252 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING / ORAL		16 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / TOPICAL	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, DELAYED RELEASE / ORAL		97 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / ORAL	914 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EXTENDED RELEASE / ORAL		320 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	GEL / OPHTHALMIC	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INHALANT / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SWAB / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACARDIAC		70 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE PELLETS / ORAL		99 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / ORAL		600 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	LOTION / TOPICAL		111 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
lauric diethanolamide	LAURIC DIETHANOLAMIDE	I29I2VHG38	SHAMPOO, SUSPENSION / TOPICAL	4 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PARENTERAL		584 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	SHAMPOO / TOPICAL	65 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	ENEMA / RECTAL	0.7 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	DROPS / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED PELLETS / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
lauric diethanolamide	LAURIC DIETHANOLAMIDE	I29I2VHG38	LOTION / TOPICAL	0.6 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C Green NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	TABLET / ORAL		240 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	DROPS / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAVITARY	0.82 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / SUBCUTANEOUS		26 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	DROPS / OPHTHALMIC	0.08 %w/w		Exact identifier — unii candidate 134 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
78e78f82-6420-4685-9d37-588346d05ef9			7c149887-b375-46d4-ac78-4f838464111e	2012-09-12	Warnings	Exact identifier spl id: 78e78f82-6420-4685-9d37-588346d05ef9 spl set id: 7c149887-b375-46d4-ac78-4f838464111e

Reported adverse events (FAERS/openFDA)#

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