FDA.reportPublic FDA data

Hydrogen Peroxide

Manufacturer
Sam's West, Inc
Effective date
2026-03-03
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:48:51

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 if bandages, let dry first apply small amount of 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 out. Do not swallow. us...

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 or 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 bandages, let dry first
  • apply small amount of 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 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

SPL UNCLASSIFIED 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 

TOPICAL SOLUTION, 3% USP

First Aid Antiseptic/

Oral Debriding Agent

  • FOR USE AS A GARGLE OR RINSE
  • FOR TREATMENT OF MINOR CUTS AND ABRASIONS

For comments or suggestions, call us toll-free at 1-877-753-3935 Monday-Friday 9:00AM-5:00PM EST

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

FL OZ (mL)

DISTRIBUTED BY:

SAM'S WEST, INC.

BENTONVILLE, AR 72716

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MEMBER'S MARK (Sam's West) Hydrogen Peroxide 3 %
MEMBER'S MARK (Sam's West) Hydrogen Peroxide 3 %

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN9
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD9
91349hydrogen peroxide 3 % Topical SolutionSY9

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130078742092744GTIN-13: 0078742092744
EAN-13: 0078742092744
GTIN-12: 078742092744
UPC-A: 078742092744
GTIN storage (14 digits): 00078742092744		hydrogen-peroxide-3-percent-simply-right-1.jpg

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68196-268-322023-05-09C16284748780-1f386c649-d206-0266-e053-dadaa90a7c1aDrug Facts
68196-268-322023-01-30C16284748780-1f386c649-d206-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-268-32Hydrogen Peroxide3 Percent946 mL in 1 BOTTLE, PLASTICLIQUID9469

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROGEN PEROXIDEACTIVE INGREDIENTBBX060AN9V3
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9V3
WATERINACTIVE INGREDIENT059QF0KO0R3

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
68196-26868196-268-32

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
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDESam's West, Inc78a3e024-73da-40b7-9d9c-099fd6ca9b9e2026-03-03WarningsExact identifier
ndc (package): 68196-268-32
ndc (product): 68196-268
ndc11 (package): 68196026832
spl id: 2e018d29-571b-4f46-8a7b-64b0f59c70bc
spl set id: 78a3e024-73da-40b7-9d9c-099fd6ca9b9e

Reported adverse events (FAERS/openFDA)#

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