FDA.reportPublic FDA data

980 Hydrogen Peroxide Solution

Manufacturer
Medline Industries, LP
Effective date
2026-02-11
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:43:53

Label at a glance#

ProductHydrogen peroxide
Active ingredientHYDROGEN PEROXIDE
Label structure9 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

First aid antiseptic: clean the affected area apply a small amount of product on the affected area 1 to 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, then spit out use up to 4 times daily after meals and at bedtime chi...

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

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 1 week

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

deep or puncture wounds, animal bites or serious burns

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

First aid antiseptic:

  • clean the affected area
  • apply a small amount of product on the affected area 1 to 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, 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

OTHER SAFETY INFORMATION

Keep tightly closed. Protect from freezing, avoid excessive heat. Do not shake bottle. Hold away from face when opening.

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified water

Manufacturing Information

SPL UNCLASSIFIED SECTION

Made in US with US and foreign components for:
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA

www.medline.com
1-800-MEDLINE (633-5463)
REF: MDS098014

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN6
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD6
91349hydrogen peroxide 3 % Topical SolutionSY6

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)10080196171293GTIN-14: 10080196171293
GTIN storage (14 digits): 10080196171293		MDS098014 V1 RJ24VJO.jpg

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
53329-980-04Hydrogen peroxide118 mL in 1 BOTTLESOLUTION1186
53329-980-08Hydrogen peroxide236 mL in 1 BOTTLESOLUTION2366

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
53329-98053329-980-04, 53329-980-08

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-10-21monthly-update2026-06-03 17:38:14
42024-05-29full-release2026-06-01 00:13:07

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 PEROXIDEMedline Industries, LP26a67a91-ee2d-6a6c-e054-00144ff88e882026-02-11WarningsExact identifier
ndc (package): 53329-980-08
ndc (package): 53329-980-04
ndc (product): 53329-980
ndc11 (package): 53329098004
ndc11 (package): 53329098008
spl id: 4a8e50e4-cfc1-e988-e063-6394a90a259f
spl set id: 26a67a91-ee2d-6a6c-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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