SOLUTION OF HYDROGEN PEROXIDE 3% USP 10 VOLUME

Manufacturer
Healthwell
Effective date
2020-10-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:31:12

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 - WHEN USING 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 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 - 946 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tamper evident cap for your protection

if ring-band is broken or missing, do not use.

Part # HSN2239

NDC #87010-001-32

HYDROGEN PEROXIDE

3% USP 10 VOLUME

3%

FIRST AID ANTISEPTIC
Made in USA

32 FL. OZ. (946 mL)

peroxideperoxide

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN3
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD3
91349hydrogen peroxide 3 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
87010-001-162022-01-28C16284748780-1d6a99b39-b078-a426-e053-dadaa90af4c2SOLUTION OF HYDROGEN PEROXIDE 3% USP 10 VOLUME
87010-001-322022-01-28C16284748780-1d6a99b39-b078-a426-e053-dadaa90af4c2SOLUTION OF HYDROGEN PEROXIDE 3% USP 10 VOLUME

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87010-001-16Hydrogen Peroxide473 mL in 1 BOTTLE, PLASTICSOLUTION4733
87010-001-32Hydrogen Peroxide946 mL in 1 BOTTLE, PLASTICSOLUTION9463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
87010-001HYDROGEN PEROXIDE SOLUTION [HEALTHWELL]3Legacy NDC, 2 package rows20201008_f654523f-69d5-42eb-90a7-ad2fb9584ea3.zip

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
87010-00187010-001-16, 87010-001-32

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

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
f787c36b-cdcf-4560-8ceb-06bf320b8419f654523f-69d5-42eb-90a7-ad2fb9584ea32020-10-07WarningsExact identifier
spl id: f787c36b-cdcf-4560-8ceb-06bf320b8419
spl set id: f654523f-69d5-42eb-90a7-ad2fb9584ea3

Reported adverse events (FAERS/openFDA)#

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