FDA.reportPublic FDA data

Hydrogen Peroxide

Manufacturer
Good Sense (Geiss, Destin & Dunn, Inc.)
Effective date
2025-03-03
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:56:35

Label at a glance#

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

Dosage and administration

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

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 

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrogen Peroxide 3%

Topical Solution USP

  • First Aid Antiseptic
  • Oral Debriding Agent

FL OZ (mL)

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

Distributed by: Perrigo Direct, Inc. Peachtree City, GA 30269 www.PerrigoDirect.com

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

 

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOODSENSE Hydrogen Peroxide 3%
GOODSENSE Hydrogen Peroxide 3%

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN5
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD5
91349hydrogen peroxide 3 % Topical SolutionSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-156-16Hydrogen Peroxide3 Percent473 mL in 1 BOTTLE, PLASTICLIQUID4735

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-156HYDROGEN PEROXIDE 3 PERCENT (HYDROGEN PEROXIDE) LIQUID [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]5Current NDC, Legacy NDC, 1 package rows20250305_cfe9be26-e4a4-413c-a602-2f5948e3bb7a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-156-16ML - Milliliter50804-1568336ac87-590a-48e6-80a2-e9ec4f25c4e812024-02-14

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
50804-15650804-156-16

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
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
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEGood Sense (Geiss, Destin & Dunn, Inc.)cfe9be26-e4a4-413c-a602-2f5948e3bb7a2025-03-03WarningsExact identifier
ndc (package): 50804-156-16
ndc (product): 50804-156
ndc11 (package): 50804015616
spl id: 67fcc841-b393-4c49-9e1d-30429c94b78d
spl set id: cfe9be26-e4a4-413c-a602-2f5948e3bb7a

Reported adverse events (FAERS/openFDA)#

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