FDA.reportPublic FDA data

HYDROGEN PEROXIDE TOPICAL SOLUTION USP

Manufacturer
DEGASA SA DE CV
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:58:54

Label at a glance#

ProductHYDROGEN PEROXIDE
Active ingredientHYDROGEN PEROXIDE
Label structure8 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 ocassional sore mouth.

Dosage and administration

First aid antiseptic: √ Clean the affected area. √ Apply a small amount of product on the affected area 1 o 3 times a day √ May be covered with a sterile bandage. √ If bandaged, let dry first. Oral debriding agent: Adults, children over 2 years of age: √ Mix with an equal amount of water. √ Swish around in the mouth over the affected area for at least 1 minute, and then spit out. √ Use up to 4 times daily after me...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide (stabilized) 3%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic Oral debriding agent

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Purified water

Uses:

INDICATIONS & USAGE SECTION

First aid to help prevent the risk of infection in minor cuts, scrapes and burnsAids in the removal of phlegm, mucus, or other secretions associated with ocassional 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 1 week.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • The condition persists or gets worse.
  • Sore mouth symptoms do not improve in 7 days
  • Irritation, pain, or redness persists or worsens
  • Swelling, rash, or fever develops.

OTC - ASK DOCTOR SECTION

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

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

First aid antiseptic:

√ Clean the affected area.

√ Apply a small amount of product on the affected area 1 o 3 times a day

√ May be covered with a sterile bandage.

√ If bandaged, let dry first.

Oral debriding agent:

Adults, children over 2 years of age:

√ Mix with an equal amount of water.

√ Swish around in the mouth over the affected area for at least 1 minute, and then spit out.

√ Use up to 4 times daily after meals and at bedtime.

√ Children under 12 years of age should be supervised in the use.

√ Children under 2 years of age: consult a dentist, doctor.

Other Information

SPL UNCLASSIFIED SECTION

√ Keep tightly closed and at controlled room temperature.

√ Do not shake bottle.

√ Hold away form face when opening.

Question or comments?

OTC - QUESTIONS SECTION

Call 956 728-8899

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN3
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD3
91349hydrogen peroxide 3 % Topical SolutionSY3

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67326-354-01HYDROGEN PEROXIDE946 mL in 1 BOTTLELIQUID9463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67326-354HYDROGEN PEROXIDE LIQUID [DEGASA SA DE CV]3Current NDC, Legacy NDC, 1 package rows20231106_26bae595-6e76-4946-b98f-1aba2e69250d.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
67326-35467326-354-01

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
HYDROGEN PEROXIDEHYDROGEN PEROXIDEDEGASA SA DE CV26bae595-6e76-4946-b98f-1aba2e69250d2023-11-05WarningsExact identifier
ndc (package): 67326-354-01
ndc (product): 67326-354
ndc11 (package): 67326035401
spl id: 09735aeb-7410-4078-e063-6394a90a065d
spl set id: 26bae595-6e76-4946-b98f-1aba2e69250d

Reported adverse events (FAERS/openFDA)#

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