FDA.reportPublic FDA data

Hydrogen Peroxide

Manufacturer
McKesson Medical-Surgical Inc.
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
monthly-update
Hydrated at
2026-06-03 17:52:23

Label at a glance#

ProductHydrogen Peroxide
Active ingredientHYDROGEN PEROXIDE
Label structure12 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 meals and ...

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 - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-2301-6

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. Tamper evident cap
for your protection. If ring-band is detached from
cap or missing, do not use.

16FL OZ (1 pt)
(473 mL)

MFR # 23-D0012

Distributed By McKesson Medical-Surgical Inc.

Richmond, VA 23233

LU-5750-1112 1-07-D0012R10

Made in USA 23-D0012 each23-D0012 each

PRINCIPAL DISPLAY PANEL - 473 mL Drug facts panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts

23-D001223-D0012

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

23-F001023-F001068599-2301-2

McKesson

Hydrogen Peroxide 3%

118mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN15
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD15
91349hydrogen peroxide 3 % Topical SolutionSY15

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130612479166431GTIN-13: 0612479166431
EAN-13: 0612479166431
GTIN-12: 612479166431
UPC-A: 612479166431
GTIN storage (14 digits): 00612479166431		23-D0012 drug facts.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-2301-2Hydrogen Peroxide118 mL in 1 BOTTLE, PLASTICSOLUTION11815
68599-2301-6Hydrogen Peroxide473 mL in 1 BOTTLE, PLASTICSOLUTION47315
68599-2301-9Hydrogen Peroxide3785 mL in 1 BOTTLE, PLASTICSOLUTION378515

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
68599-230168599-2301-2, 68599-2301-6, 68599-2301-9

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 · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
142024-11-15full-release2026-06-01 00:37:39

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.fefaf5ff-e5f4-40d9-a415-a54fb5592ae12026-01-08WarningsExact identifier
ndc (package): 68599-2301-9
ndc (package): 68599-2301-2
ndc (package): 68599-2301-6
ndc (product): 68599-2301
ndc11 (package): 68599230106
ndc11 (package): 68599230102
ndc11 (package): 68599230109
spl id: 47e655f1-62dc-848a-e063-6294a90aa3c8
spl set id: fefaf5ff-e5f4-40d9-a415-a54fb5592ae1

Reported adverse events (FAERS/openFDA)#

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