Drug Facts

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER 70000
Effective date
2026-10-01
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-10-06 02:02:17

Label at a glance#

ProductHydrogen Peroxide 3 Percent
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, mucus, or other secretions associated with occasional sore mouth

Dosage and administration

For use as a first aid antiseptic: clean affected area if bandaged, let dry first apply small amount if product on affected area 1-3 times a day may be covered with a sterile bandage For use as an 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 affected area for at least 1 minute and then spit it out. Do not swallow. u...

Storage and handling

keep tightly closed and in a dark place at room temperature do not shake bottle. Hold away from face when opening

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

 Hydrogen peroxide 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 one week

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep puncture wounds, animal bites or serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • swelling, rash, or fever develops
  • the condition persists or gets worse
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For use as a first aid antiseptic:

  • clean affected area
  • if bandaged, let dry first
  • apply small amount if product on affected area 1-3 times a day
  • may be covered with a sterile bandage

For use as an 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 affected area for at least 1 minute and then spit it out. Do not swallow.
    • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
  • children under 12 years should be supervised in the use of this product
  • children under 2 years of age: consult a doctor or dentist 

Other information

STORAGE AND HANDLING SECTION

  • keep tightly closed and in a dark place at room temperature
  • do not shake bottle. Hold away from face when opening

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified water 

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrogen Peroxide

3% USP

First Aid Antiseptic

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN OHIO 43017

www.myleader.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER Hydrogen Peroxide 3% USP
LEADER Hydrogen Peroxide 3% USP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295137033GTIN-13: 0096295137033
EAN-13: 0096295137033
GTIN-12: 096295137033
UPC-A: 096295137033
GTIN storage (14 digits): 00096295137033
hydrogen-peroxide-3-percent-usp-1.jpg

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0500-1ML - Milliliter70000-0500c1b6cf94-9645-4f14-a2d0-13f70feeb8ed12019-09-05
70000-0500-2ML - Milliliter70000-050037653585-c44d-434a-bb3c-1b2d22b7eea812019-11-12

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
70000-050070000-0500-1, 70000-0500-2

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
HYDROGEN PEROXIDEBBX060AN9VACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-07-11full-release2026-06-01 01:07:00

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
adc6b003-fab8-4fff-a54a-d2e203ac99ff1cd343f3-00aa-42e9-b57d-7b4587341d0e2025-07-11WarningsExact identifier
spl set id: 1cd343f3-00aa-42e9-b57d-7b4587341d0e

Reported adverse events (FAERS/openFDA)#

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