BerbereX Wound Cleanser

Manufacturer: Cosmetic Specialty Labs, Inc.
Effective date: 2014-01-23
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:38:16

Label at a glance#

ProductBerbereX Wound Cleanser

Active ingredientALLANTOIN, BENZETHONIUM CHLORIDE

Label structure8 sections

Indications and uses

helps protect skin and supports healing of minor cuts, scapes, bums and wounds, including pressure sores, diabetic ulcers, cracked skin and lips. topical antiseptic to help decrease the risk of skin infections

Dosage and administration

Use to clean minor cut, scrapes and burns by thoroughly flushing the affected area; let air dry; cover with adhesive bandage or sterile gauze; apply a small amount of this product on the area 1 to 3 times daily do not use, consult a doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%
Benzethonium Chloride 0.1%

PURPOSE

OTC - PURPOSE SECTION

Skin Protectant
Antiseptic

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison control center immediately.

USES

INDICATIONS & USAGE SECTION

helps protect skin and supports healing of minor cuts,

scapes, bums and wounds, including pressure sores, diabetic

ulcers, cracked skin and lips. topical antiseptic to help decrease

the risk of skin infections

WARNINGS

WARNINGS SECTION

for external use only

Do not use

SPL UNCLASSIFIED SECTION

in large quantities, particularly over raw surfaces or blistered areas

Ask a doctor before use if you have

SPL UNCLASSIFIED SECTION

deep or puncture wounds
animal bites
serious bums

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

condition worsens
symptoms perist for more than 7days or clear up and occur again within a few days

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 2years of age and older

SPL UNCLASSIFIED SECTION

Children under 2years of age

SPL UNCLASSIFIED SECTION

do not use, consult a doctor

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe barbadensis Mill, Ethanol, Hydrastis canadensis L., Hydrogen Peroxide, Panax quinquefolis L.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1437628	allantoin 5 MG/ML / benzethonium chloride 1 MG/ML Topical Solution	allantoin 5 MG/ML / benzethonium chloride 1 MG/ML Topical Solution	SCD Active
1487627	allantoin 5 MG/ML / benzethonium chloride 1 MG/ML Topical Solution [Berberex Wound Cleanser]	allantoin 5 MG/ML / benzethonium chloride 1 MG/ML Topical Solution [Berberex Wound Cleanser]	SBD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1437628	allantoin 0.5 % / benzethonium chloride 0.1 % Topical Solution	PSN	3
1487627	BerbereX Wound Cleanser 0.5 % / 0.1 % Topical Solution	PSN	3
1487627	allantoin 5 MG/ML / benzethonium chloride 1 MG/ML Topical Solution [Berberex Wound Cleanser]	SBD	3
1437628	allantoin 5 MG/ML / benzethonium chloride 1 MG/ML Topical Solution	SCD	3
1437628	allantoin 0.5 % / benzethonium chloride 0.1 % Topical Solution	SY	3
1487627	Berberex Wound Cleanser (allantoin 0.5 % / benzethonium chloride 0.1 % ) Topical Solution	SY	3
1487627	Berberex Wound Cleanser (allantoin 5 MG/ML / benzethonium chloride 1 MG/ML) Topical Solution	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58133-055-04	2020-01-31	C162847	48780-1	9d75b9d0-a22b-f424-e053-dadaa90a57ce	cd8c1230-f356-4587-8e49-4c7db6e09849
58133-055-08	2020-01-31	C162847	48780-1	9d75b9d0-a22b-f424-e053-dadaa90a57ce	cd8c1230-f356-4587-8e49-4c7db6e09849
58133-055-16	2020-01-31	C162847	48780-1	9d75b9d0-a22b-f424-e053-dadaa90a57ce	cd8c1230-f356-4587-8e49-4c7db6e09849

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58133-055-04	BerbereX Wound Cleanser	118 mL in 1 BOTTLE	SOLUTION	118	3
58133-055-08	BerbereX Wound Cleanser	236 mL in 1 BOTTLE	SOLUTION	236	3
58133-055-16	BerbereX Wound Cleanser	473 mL in 1 BOTTLE	SOLUTION	473	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58133-055	BERBEREX WOUND CLEANSER (ALLANTOIN, BENZETHONIUM CHLORIDE) SOLUTION [COSMETIC SPECIALTY LABS, INC.]	3	Legacy NDC, 3 package rows	20140131_cd8c1230-f356-4587-8e49-4c7db6e09849.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ALLANTOIN	ACTIVE INGREDIENT	344S277G0Z	3
BENZETHONIUM CHLORIDE	ACTIVE INGREDIENT	PH41D05744	3
ALLANTOIN	ACTIVE MOIETY	344S277G0Z	3
BENZETHONIUM	ACTIVE MOIETY	1VU15B70BP	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	3
ALOE VERA WHOLE	INACTIVE INGREDIENT	KIZ4X2EHYX	3
HYDRASTIS CANADENSIS WHOLE	INACTIVE INGREDIENT	R763EBH88T	3
Hydrogen Peroxide	INACTIVE INGREDIENT	BBX060AN9V	3
PANAX QUINQUEFOLIUS WHOLE	INACTIVE INGREDIENT	0P067WOA1X	3

Products#

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

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

BerbereX Wound Cleanser
Allantoin, Benzethonium Chloride
ALLANTOIN
BENZETHONIUM CHLORIDE
BENZETHONIUM
ALOE VERA WHOLE
ALCOHOL
HYDRASTIS CANADENSIS WHOLE
Hydrogen Peroxide
PANAX QUINQUEFOLIUS WHOLE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58133-055	58133-055-04, 58133-055-08, 58133-055-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALLANTOIN	344S277G0Z	ACTIB
BENZETHONIUM CHLORIDE	PH41D05744	ACTIB
ALOE VERA WHOLE	KIZ4X2EHYX	IACT
ALCOHOL	3K9958V90M	IACT
HYDRASTIS CANADENSIS WHOLE	R763EBH88T	IACT
Hydrogen Peroxide	BBX060AN9V	IACT
PANAX QUINQUEFOLIUS WHOLE	0P067WOA1X	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 2 · 62 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / BUCCAL	679 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Hydrogen Peroxide	HYDROGEN PEROXIDE	BBX060AN9V	SPONGE / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Hydrogen Peroxide	HYDROGEN PEROXIDE	BBX060AN9V	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 3 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY, METERED / SUBLINGUAL		29 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Hydrogen Peroxide	HYDROGEN PEROXIDE	BBX060AN9V	SOLUTION / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / DENTAL	12.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAVENOUS		400 mg	Exact identifier — unii candidate 59 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
1d8d9dbb-4554-49ea-98ea-d63e508f34fd			cd8c1230-f356-4587-8e49-4c7db6e09849	2014-01-23	Warnings	Exact identifier spl id: 1d8d9dbb-4554-49ea-98ea-d63e508f34fd spl set id: cd8c1230-f356-4587-8e49-4c7db6e09849

Reported adverse events (FAERS/openFDA)#

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

BerbereX Wound Cleanser

Label at a glance#

Indications and uses

Dosage and administration

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

PURPOSE

KEEP OUT OF REACH OF CHILDREN

USES

WARNINGS

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

DIRECTIONS

Adults and children 2years of age and older

Children under 2years of age

INACTIVE INGREDIENTS

PRINCIPAL DISPLAY PANEL

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#