HYDROGEN PEROXIDE

Manufacturer
BROSANT GROUP LLC
Effective date
2023-01-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:53:18

Label at a glance#

ProductHYDROGEN PEROXIDE
Active ingredientHYDROGEN PEROXIDE
Label structure12 sections

Indications and uses

-first aid to help prevent the risk of infection in minor cuts, scrapes and burns -aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

Dosage and administration

For use as a first aid antiseptic -clean affected area -if bandaged, let dry first -apply small amount of product on affected area 1-3 times a day -may be covered with a sterile bandage For use as an oral debriding agent (oral rinse): -adults and children 2 years of age and over: -mix with and equal amount of water -swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallo...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient
Hydrogen Peroxide 3%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic oral debriding agent

Uses

INDICATIONS & USAGE SECTION

-first aid to help prevent the risk of infection in minor cuts, scrapes and burns

-aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

-in the eyes or apply over large areas of the body

-longer than one week

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

-deep puncture wounds, animal bites or serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

-swelling, rash, or fever develops

-the condition persists or get worse

-sore mouth symptoms do not improve in 7 days

-irritation, pain, or redness persists or worsen

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

DOSAGE & ADMINISTRATION SECTION

For use as a first aid antiseptic

-clean affected area

-if bandaged, let dry first

-apply small amount of product on affected area 1-3 times a day

-may be covered with a sterile bandage

For use as an oral debriding agent (oral rinse):

-adults and children 2 years of age and over:

-mix with and equal amount of water
-swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow.

-use up 4 times daily after meals and at bedtime or as directed by a dentist or doctor

children under 12 years should be supervised in the use od this product

children under 2 years of age: consult a doctor or dentist

Other information

OTHER SAFETY INFORMATION

-keep tightly closed and in a dark place at room temperature

-do not shake botlle. Hold away from face when opening

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bioliving

3% hydrogen peroxide

topical solution USP

Tamper evident: do not use if seal under cap is broken or missing

32 FL OZ (1 QT) 946 mL
Principal DisplayPrincipal Display

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN1
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD1
91349hydrogen peroxide 3 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83123-0012-12024-07-30C16284748780-11030e365-0454-111a-e063-dadaa90a10e2f2650b0c-19ee-6f2e-e053-2995a90aaddb
83123-0012-12024-01-30C16284748780-11030e365-0454-111a-e063-dadaa90a10e2f2650b0c-19ee-6f2e-e053-2995a90aaddb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83123-0012-1HYDROGEN PEROXIDE946 mL in 1 BOTTLELIQUID9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83123-0012HYDROGEN PEROXIDE LIQUID [BROSANT GROUP LLC]11 package rows20230118_f2650b0c-19ee-6f2e-e053-2995a90aaddb.zip

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83123-001283123-0012-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGEN PEROXIDEBBX060AN9VACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

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
f2650b0c-19ef-6f2e-e053-2995a90aaddbf2650b0c-19ee-6f2e-e053-2995a90aaddb2023-01-16WarningsExact identifier
spl id: f2650b0c-19ef-6f2e-e053-2995a90aaddb
spl set id: f2650b0c-19ee-6f2e-e053-2995a90aaddb

Reported adverse events (FAERS/openFDA)#

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