BerbereX Wound Cleanser

Manufacturer
Cosco International, Inc.
Effective date
2025-05-30
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:01:53

Label at a glance#

ProductBerbereX Wound Cleanser
Active ingredientALLANTOIN, BENZETHONIUM CHLORIDE
Label structure11 sections

Dosage and administration

Adults and children 2 years of age and older: 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 Children under 2 years of age:   do not use, consult a doctor

Label contents#

Full prescribing information#

Active Ingredient/Purpose

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%........................Skin Protectant

Benzethonium Chloride 0.1%............Antiseptic

Uses

OTC - Purpose Section

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

WARNINGS SECTION

Warnings  For external use only.

Do not use 

Indications & Usage Section

  • in large quantities, particularly over raw surfaces or blistered areas

Ask doctor before use if you have

OTC - Ask Doctor Section

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask doctor if

OTC - Stop Use Section

  • condition worsens
  • symptons persist for more than 7 days or clear up and occur again within a few days

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 immediately

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older:

  • 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

Children under 2 years of age:  do not use, consult a doctor

Inactive ingredients:

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4oz label4oz label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8oz label8oz label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

16oz label16oz label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1437628allantoin 0.5 % / benzethonium chloride 0.1 % Topical SolutionPSN7
1487627BerbereX Wound Cleanser 0.5 % / 0.1 % Topical SolutionPSN7
1487627allantoin 5 MG/ML / benzethonium chloride 1 MG/ML Topical Solution [Berberex Wound Cleanser]SBD7
1437628allantoin 5 MG/ML / benzethonium chloride 1 MG/ML Topical SolutionSCD7
1437628allantoin 0.5 % / benzethonium chloride 0.1 % Topical SolutionSY7
1487627Berberex Wound Cleanser (allantoin 0.5 % / benzethonium chloride 0.1 % ) Topical SolutionSY7
1487627Berberex Wound Cleanser (allantoin 5 MG/ML / benzethonium chloride 1 MG/ML) Topical SolutionSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52261-0500-1BerbereX Wound Cleanser118 mL in 1 BOTTLE, SPRAYLIQUID1187
52261-0500-2BerbereX Wound Cleanser237 mL in 1 BOTTLE, SPRAYLIQUID2377
52261-0500-3BerbereX Wound Cleanser473 mL in 1 BOTTLE, SPRAYLIQUID4737

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0Z1
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D057441
ALLANTOINACTIVE MOIETY344S277G0Z1
BENZETHONIUMACTIVE MOIETY1VU15B70BP1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ALOE VERA WHOLEINACTIVE INGREDIENTKIZ4X2EHYX1
HYDRASTIS CANADENSIS WHOLEINACTIVE INGREDIENTR763EBH88T1
hydrogen peroxideINACTIVE INGREDIENTBBX060AN9V1
PANAX QUINQUEFOLIUS WHOLEINACTIVE INGREDIENT0P067WOA1X1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52261-050052261-0500-1, 52261-0500-2, 52261-0500-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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 · 68 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
hydrogen peroxideHYDROGEN PEROXIDEBBX060AN9VSPONGE / TOPICAL0.2 %w/wExact identifier — unii+route
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+dosage form
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
60 equally ranked IID candidates
hydrogen peroxideHYDROGEN PEROXIDEBBX060AN9VSPONGE / TOPICAL0.2 %w/wExact identifier — unii+route
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
60 equally ranked IID candidates
hydrogen peroxideHYDROGEN PEROXIDEBBX060AN9VSOLUTION / TOPICAL0.16 %w/wExact identifier — unii+route
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii+dosage form
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii+dosage form
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii+dosage form
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
60 equally ranked IID candidates
hydrogen peroxideHYDROGEN PEROXIDEBBX060AN9VSPONGE / TOPICAL0.2 %w/wExact identifier — unii+route
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
60 equally ranked IID candidates
hydrogen peroxideHYDROGEN PEROXIDEBBX060AN9VSPONGE / TOPICAL0.2 %w/wExact identifier — unii+route
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii+dosage form
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+dosage form
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
60 equally ranked IID candidates
hydrogen peroxideHYDROGEN PEROXIDEBBX060AN9VSOLUTION / TOPICAL0.16 %w/wExact identifier — unii+route
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
60 equally ranked IID candidates
hydrogen peroxideHYDROGEN PEROXIDEBBX060AN9VSOLUTION / TOPICAL0.16 %w/wExact identifier — unii+route
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+dosage form
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+dosage form
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
60 equally ranked IID candidates
hydrogen peroxideHYDROGEN PEROXIDEBBX060AN9VSOLUTION / TOPICAL0.16 %w/wExact identifier — unii+route
8 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BerbereX Wound CleanserBENZETHONIUM CHLORIDECosco International, Inc.08b28f52-21fc-4694-a163-91c8193b40082025-05-30WarningsExact identifier
ndc (package): 52261-0500-1
ndc (package): 52261-0500-3
ndc (package): 52261-0500-2
ndc (product): 52261-0500
ndc11 (package): 52261050003
ndc11 (package): 52261050002
ndc11 (package): 52261050001
spl id: d3e2c5a1-5f63-4c96-8fbe-1ba6c8c5d93d
spl set id: 08b28f52-21fc-4694-a163-91c8193b4008

Reported adverse events (FAERS/openFDA)#

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