Septicare

Manufacturer: Sage Pharmaceuticals, Inc.
Effective date: 2013-08-05
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:36:26

Label at a glance#

ProductSepticare

Active ingredientBENZETHONIUM CHLORIDE

Label structure11 sections

Indications and uses

For skin irritation due to incontinence. Protects against the risk of bacterial contamination in minor cuts, scrapes, and burns.

Dosage and administration

Adjust nozzle to spray or stream setting. Spray/stream Septicare directly into wound, or soak gauze pad and pack the wound. Cover with secondary dressing of choice. Change dressing as needed, no rinsing necessary.

Storage and handling

Store at controlled room temperature between 50°F (10°C) and 86°F (30°C).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzethonium Chloride 0.2%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For skin irritation due to incontinence. Protects against the risk of bacterial contamination in minor cuts, scrapes, and burns.

Warnings

WARNINGS SECTION

When using this product

OTC - WHEN USING SECTION

Do not use in the eyes, with deep or puncture wounds, serious burns or animal bites.

Stop using this product

OTC - STOP USE SECTION

If skin irritation and redness develop.

If condition persists for more than 72 hours, consult a physician.

SPL UNCLASSIFIED SECTION

For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, sodium chloride 0.9%, nonionic surfactant, biguanide.

STORAGE AND HANDLING SECTION

Store at controlled room temperature between 50°F (10°C) and 86°F (30°C).

SPL UNCLASSIFIED SECTION

Protocol: Shake before use. Cleaning: Spray on the affected peritoneal area and remove with a moist washcloth. Aides in the removal of urine feces and other foreign material.

SPL UNCLASSIFIED SECTION

Manufactured by:
SAGE
PHARMACEUTICALS
5408 Interstate Drive
Shreveport, LA 71109

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59243-100-08

SeptiCare™

Wound Cleanser and Deodorant

Antiseptic

Saline based • No-rinse • Non-toxic • Non-stinging

Net Contents: 8 fl.oz. (240 mL)

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1370826	benzethonium chloride 0.2 % Topical Spray	PSN	1
1432967	SeptiCare 0.2 % Topical Spray	PSN	1
1432967	benzethonium chloride 2 MG/ML Topical Spray [Septicare]	SBD	1
1370826	benzethonium chloride 2 MG/ML Topical Spray	SCD	1
1370826	benzethonium chloride 0.2 % Topical Spray	SY	1
1432967	Septicare 0.2 % Topical Spray	SY	1
1432967	Septicare 2 MG/ML Topical Spray	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59243-100-08	2019-11-27	C162847	48780-1	9855d018-d61c-cd31-e053-dbdaa90ab51a	Septicare™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59243-100-08	Septicare	240 mL in 1 BOTTLE, SPRAY	SOLUTION	240		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59243-100	SEPTICARE (BENZETHONIUM CHLORIDE) SOLUTION [SAGE PHARMACEUTICALS, INC.]	1	Legacy NDC, 1 package rows	20130806_cd731ea7-75bf-4369-ba68-127f07af3e42.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZETHONIUM CHLORIDE	ACTIVE INGREDIENT	PH41D05744	1
BENZETHONIUM	ACTIVE MOIETY	1VU15B70BP	1
POLIHEXANIDE	INACTIVE INGREDIENT	322U039GMF	1
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Septicare
BENZETHONIUM CHLORIDE
BENZETHONIUM
SODIUM CHLORIDE
POLOXAMER 188
POLIHEXANIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59243-100	59243-100-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZETHONIUM CHLORIDE	PH41D05744	ACTIB
SODIUM CHLORIDE	451W47IQ8X	IACT
POLOXAMER 188	LQA7B6G8JG	IACT
POLIHEXANIDE	322U039GMF	IACT
WATER	059QF0KO0R	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 3 · 156 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLOXAMER 188	POLOXAMER 188	LQA7B6G8JG	GRANULE / ORAL		81 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVENOUS		28773 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE / ORAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
POLOXAMER 188	POLOXAMER 188	LQA7B6G8JG	POWDER, FOR SUSPENSION / INTRAMUSCULAR	0.2 %w/v		Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / TOPICAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVENOUS	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
POLOXAMER 188	POLOXAMER 188	LQA7B6G8JG	SOLUTION / ORAL		1800 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SPRAY / NASAL		30 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	IMPLANT / SUBCUTANEOUS	77 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INHALANT / RESPIRATORY (INHALATION)	3 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / AURICULAR (OTIC)		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
POLOXAMER 188	POLOXAMER 188	LQA7B6G8JG	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POLOXAMER 188	POLOXAMER 188	LQA7B6G8JG	GEL / PERIODONTAL	55 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RESPIRATORY (INHALATION)		108 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / TOPICAL	0.23 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	ELIXIR / ORAL	1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, EMULSION / INTRAVENOUS	0.62 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
POLOXAMER 188	POLOXAMER 188	LQA7B6G8JG	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	2.2 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / OPHTHALMIC	0.08 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVITREAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / NASAL	330 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / OPHTHALMIC		10 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL		11 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / RETROBULBAR		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
POLOXAMER 188	POLOXAMER 188	LQA7B6G8JG	SOLUTION / OPHTHALMIC	0.1 %w/v		Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ENDOTRACHEAL	7.6 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRAMUSCULAR	9 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	JELLY / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / OPHTHALMIC	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAVENOUS		2916 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
POLOXAMER 188	POLOXAMER 188	LQA7B6G8JG	TABLET, COATED / ORAL	3 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBMUCOSAL		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
POLOXAMER 188	POLOXAMER 188	LQA7B6G8JG	POWDER, FOR SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERINEURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / OPHTHALMIC		13 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRALESIONAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, EXTENDED RELEASE / ORAL	335.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
POLOXAMER 188	POLOXAMER 188	LQA7B6G8JG	CAPSULE / ORAL		151 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / EPIDURAL		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / EPIDURAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVENOUS		90 mg	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
e3cd2717-4e68-4fa1-9ca9-4d0aee15a933			cd731ea7-75bf-4369-ba68-127f07af3e42	2013-08-05	Warnings	Exact identifier spl id: e3cd2717-4e68-4fa1-9ca9-4d0aee15a933 spl set id: cd731ea7-75bf-4369-ba68-127f07af3e42

Reported adverse events (FAERS/openFDA)#

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