FDA.reportPublic FDA data

Hydrogen Peroxide

Manufacturer
Henry Schein Inc.
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
monthly-update
Hydrated at
2026-06-03 17:52:21

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 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 a day may be covered with a sterile bandage if bandaged, let dry first Oral Debriding Agent (oral rinse): Adults and children 2 years of age & 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 ...

Storage and handling

Keep tightly closed in a cool dark place 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 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 havedeep 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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

First Aid Antiseptic
  • clean the affected area
  • apply a small amount of product on the area 1 to 3 times a day
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Oral Debriding Agent (oral rinse):

Adults and children 2 years of age & 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 in a cool dark place
  • Do not shake bottle
  • Hold away from face when opening

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Purified Water

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-472-4346

PRINCIPAL DISPLAY PANEL - 3.79 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Item # 112-7070
NDC 0404-0001-01

HENRY SCHEIN ®

3 % Hydrogen
Peroxide Solution

U.S.P. FIRST AID ANTISEPTIC
Tamper evident cap for your protection. If ring-band
is detached from cap or missing do not use.

Distributed by (in US Only):

HENRY SCHEIN INC.
135 Duryea Road
Melville, NY 11747 USA

Rev. Date 2018/06 Made in the USA

128 FL OZ (1 Gal.) • 3.79 L

Principal Display Panel - 3.79 L Bottle LabelPrincipal Display Panel - 3.79 L Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN12
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD12
91349hydrogen peroxide 3 % Topical SolutionSY12

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128+H658112707009peroxide-01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0001-01Hydrogen Peroxide3785 mL in 1 BOTTLE, PLASTICSOLUTION378512
0404-0001-08Hydrogen Peroxide237 mL in 1 BOTTLE, PLASTICSOLUTION23712
0404-0001-16Hydrogen Peroxide473 mL in 1 BOTTLE, PLASTICSOLUTION47312

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
0404-00010404-0001-01, 0404-0001-08, 0404-0001-16

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
112024-11-15full-release2026-06-01 00:37:36

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 PEROXIDEHenry Schein Inc.d97671f0-b182-4dab-87d2-cf9919509da52026-01-08WarningsExact identifier
ndc (package): 0404-0001-01
ndc (package): 0404-0001-08
ndc (package): 0404-0001-16
ndc (product): 0404-0001
ndc11 (package): 00404000116
ndc11 (package): 00404000101
ndc11 (package): 00404000108
spl id: 47e66953-6cd5-9f40-e063-6294a90a48a3
spl set id: d97671f0-b182-4dab-87d2-cf9919509da5

Reported adverse events (FAERS/openFDA)#

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