FDA.reportPublic FDA data

Hydrogen Peroxide

Manufacturer
McKesson Medical-Surgical Inc. | Hydrox Laboratories
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
monthly-update
Hydrated at
2026-06-03 17:51:38

Label at a glance#

ProductHydrogen Peroxide
Active ingredientHYDROGEN PEROXIDE
Label structure10 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, mucous, 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 area 1 to 3 times daily May be covered with a sterile bandage If bandaged, let dry first   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 the affected area for at least 1 minute and then spit out Use up to 4 times daily after meal...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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, mucous, or other secretions associated with occasional sore mouth

Warnings

WARNINGS SECTION

  • For external use only

OTC - DO NOT USE SECTION

  • Do not use
    • in the eyes or apply over large areas of the body
    • longer than 1 week

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

  • Stop use and ask a doctor if
    • 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 - 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 area 1 to 3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first
  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 the affected area for at least 1 minute and then spit out
  • Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
  • Children under 12 years of age 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 at controlled room temperature. Do not shake bottle. Hold away from face when opening.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

purified water

SPL UNCLASSIFIED SECTION

Distributed By McKesson Medical-Surgical Inc.
Richmond, VA 23228

PRINCIPAL DISPLAY PANEL - 3.8 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-2305-9

McKESSON

Hydrogen

Peroxide 3%

TOPICAL SOLUTION USP

FIRST AID ANTISEPTIC

ORAL DEBRIDING AGENT

For treatment of minor cuts and abrasions.

For use as a gargle or rinse.

1

GALLON

(3.8 L)

TAMPER EVIDENT CAP FOR YOUR PROTECTION.

IF RING-BANDIS DETACHED FROM CAP OR MISSING DO NOT USE.

Distributed By McKesson Medical-Surgical Inc.

Richmond, VA 23233

VPN B0819

Made in USA

MFR # 23-A0013

Case

EachEach

casecase

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN14
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD14
91349hydrogen peroxide 3 % Topical SolutionSY14

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
68599-2305-92021-02-09C16284748780-1ba0f9c33-545f-a910-e053-dadaa90a0b85Hydrogen Peroxide
68599-2305-92021-02-09C16284748780-1ba0f9c33-545f-a910-e053-dadaa90a0b85Hydrogen Peroxide
68599-2305-92021-01-29C16284748780-1ba0f9c33-545f-a910-e053-dadaa90a0b85Hydrogen Peroxide
68599-2305-92021-01-29C16284748780-1ba0f9c33-545f-a910-e053-dadaa90a0b85Hydrogen Peroxide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-2305-9Hydrogen Peroxide3800 mL in 1 BOTTLE, PLASTICSOLUTION380014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Hydrogen PeroxideACTIVE INGREDIENTBBX060AN9V1
Hydrogen PeroxideACTIVE MOIETYBBX060AN9V1
WaterINACTIVE INGREDIENT059QF0KO0R1

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
68599-230568599-2305-9

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
132024-11-15full-release2026-06-01 00:37:28

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 PEROXIDEMcKesson Medical-Surgical Inc.85d2d57d-6d0b-406a-8880-a697a8c3c6822026-01-08WarningsExact identifier
ndc (package): 68599-2305-9
ndc (product): 68599-2305
ndc11 (package): 68599230509
spl id: 47e6673d-e430-41c4-e063-6394a90a11b5
spl set id: 85d2d57d-6d0b-406a-8880-a697a8c3c682

Reported adverse events (FAERS/openFDA)#

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