Hydrogen Peroxide

Manufacturer
Dyad Medical Sourcing, LLC
Effective date
2024-11-14
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:37:18

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, 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 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 the removal of phlegm, mucous, or other secretions associated with occasional sore mouth

Warnings 

WARNINGS SECTION

OTC - DO NOT USE SECTION

For external use only

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 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

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 in a cool dark place. Do not shake bottle. Hold away from face when opening.

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified water

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HCS

NDC 53175-001-16

Solution of
Hydrogen Peroxide
3% USP 10 Volume


FIRST AID ANTISEPTIC
ORAL DEBRIDING AGENT

For treatment of minor cuts, scrapes and burns

For use as a gargle or rinse

For external use only

SEALED FOR YOUR PROTECTION

IF SEAL IS BROKEN OR MISSING DO NOT USE

Manufactured for:Dyad Medical Sourcing, LLC

2101 Waukegan Road, Suite 208 Bannockburn, IL 60015

1-855-241-1773 • info@dyadms.com

Made in USA #902-HCS0202 Rev. 02

©2020 Dyad Medical Sourcing, LLC www.hcsmed.com

Reorder No. HCS0202

16 FL OZ (1 PT) 473 mL

PRINCIPAL DISPLAY PANEL - 473 mL Bottle LabelPRINCIPAL DISPLAY PANEL - 473 mL Bottle LabelBack PanelBack Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN11
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD11
91349hydrogen peroxide 3 % Topical SolutionSY11

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
53175-001-04Hydrogen Peroxide118 mL in 1 BOTTLELIQUID11811
53175-001-08Hydrogen Peroxide237 mL in 1 BOTTLELIQUID23711
53175-001-16Hydrogen Peroxide473 mL in 1 BOTTLELIQUID47311

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53175-001HYDROGEN PEROXIDE LIQUID [DYAD MEDICAL SOURCING, LLC]11Legacy NDC, 3 package rows20241116_1e7c47f2-c4ea-4853-b597-d0e5e002a202.zip

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
53175-00153175-001-04, 53175-001-08, 53175-001-16

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 · Source PDF

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
26e2d5bb-fa14-9311-e063-6394a90a8ec91e7c47f2-c4ea-4853-b597-d0e5e002a2022024-11-14WarningsExact identifier
spl id: 26e2d5bb-fa14-9311-e063-6394a90a8ec9
spl set id: 1e7c47f2-c4ea-4853-b597-d0e5e002a202

Reported adverse events (FAERS/openFDA)#

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