3% Hydrogen Peroxide

Manufacturer
MBS Medical Technologies, Inc. | MBS Medical Technologies Inc
Effective date
2020-09-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:27

Label at a glance#

Product3% Hydrogen Peroxide
Active ingredientHYDROGEN PEROXIDE
Label structure9 sections

Storage and handling

*Keep tightly closed and in a dark place at room temperature. *Do not shake bottle. Hold away from face when opening.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen peroxide 3%

Purpose

OTC - PURPOSE SECTION

first aid antiseptic / oral debriding agent

INDICATIONS & USAGE SECTION

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.

Warnings

WARNINGS SECTION

For external use only.

Do not use *in the eyes or apply over large areas of the body. *longer than one week.

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

Stop use and ask a doctor if *swelling, rash, or fever develops. *the condition persists or gets worse. *sore mouth symptoms do not improve in 7 days. *irritation, pain or redness persists or worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact poison control center right away.

DOSAGE & ADMINISTRATION SECTION

Directions 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 an 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 to 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 of this product. * children under 2 years of age: consult a dentist or doctor.

Other information

STORAGE AND HANDLING SECTION

*Keep tightly closed and in a dark place at room temperature.

*Do not shake bottle. Hold away from face when opening.

INACTIVE INGREDIENT SECTION

Inactive ingredient purified water

SPL UNCLASSIFIED SECTION

Antiseptic

* For treatment of minor cuts and abrasions.

* Oral debriding agent.

* Use as a gargle or rinse.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3% H2O23% H2O2

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
79590-001-002022-01-28C16284748780-1d6a99b39-fb68-a426-e053-dadaa90af4c23% Hydrogen Peroxide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79590-001-003% Hydrogen Peroxide475 mL in 1 BOTTLE, PLASTICLIQUID4751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79590-0013% HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) LIQUID [MBS MEDICAL TECHNOLOGIES, INC.]1Legacy NDC, 1 package rows20200916_af622cd6-fb9d-d32e-e053-2a95a90a2919.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79590-00179590-001-00

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
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VACTIB

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
af622d94-71e5-3f57-e053-2995a90abb8caf622cd6-fb9d-d32e-e053-2a95a90a29192020-09-15WarningsExact identifier
spl id: af622d94-71e5-3f57-e053-2995a90abb8c
spl set id: af622cd6-fb9d-d32e-e053-2a95a90a2919

Reported adverse events (FAERS/openFDA)#

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