Hydrogen Peroxide Topical Solution U.S.P

Manufacturer
Economy Polymers and Chemicals
Effective date
2021-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:46

Label at a glance#

ProductHydrogen Peroxide Topical Solution U.S.P
Active ingredientHYDROGEN PEROXIDE
Label structure7 sections

Indications and uses

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide 3%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

USES

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For External Uses only, avoid swallowing

DO NOT USE

OTC - DO NOT USE SECTION

in the eyes or apply over large areas of the body longer than one week.

Stop use and ask doctor if:

OTC - STOP USE SECTION

condition persist or worsens, sore mouth symptoms do not improve in 7 days irritation pain or redenss persists or worsens swelling, rash of fever develops. Deep puncture wounds animal bites or serious burns.

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 right away.

DIRECCTION FOR USE A FIRST AID ANTISEPTIC

DOSAGE & ADMINISTRATION SECTION

Clean affected area. Apply small amount of product on affected area 1-3 times day. May be covered with a sterile bandage. If bandaged let dry first.

FOR USE AS AN ORAL RINSE AGENT

Adults and children 2 years of age and over: mix with an equal amount of water. Swish around mouth over the affected area for at least 1 minute and then spilt out. Do Not Swallow. Use up to 4 times daily or as directed by your dentist or doctor.

Other Information

SPL UNCLASSIFIED SECTION

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

Inactive Ingredient

INACTIVE INGREDIENT SECTION

USP Water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74830-002-012023-01-30C16284748780-1f386c64a-4860-0266-e053-dadaa90a7c1aHydrogen Peroxide Topical Solution U.S.P.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74830-002-01Hydrogen Peroxide Topical Solution U.S.P473 mL in 1 BOTTLESOLUTION4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74830-002HYDROGEN PEROXIDE TOPICAL SOLUTION U.S.P (HYDROGEN PEROXIDE) SOLUTION [ECONOMY POLYMERS AND CHEMICALS]1Legacy NDC, 1 package rows20210307_25d77750-8904-4f5f-85ba-8efe9ba9d3e3.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
74830-00274830-002-01

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
bccc7855-92fa-f45a-e053-2a95a90a00cf25d77750-8904-4f5f-85ba-8efe9ba9d3e32021-03-05WarningsExact identifier
spl id: bccc7855-92fa-f45a-e053-2a95a90a00cf
spl set id: 25d77750-8904-4f5f-85ba-8efe9ba9d3e3

Reported adverse events (FAERS/openFDA)#

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