FDA.reportPublic FDA data

Hydrogen Peroxide

Manufacturer
SMART SENSE (Kmart)
Effective date
2020-11-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:08:26

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 of 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 out. Do not swallow. u...

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

  • 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

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 of 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 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 dentist or doctor

Other information

SPL UNCLASSIFIED SECTION

  • Keep tightly closed and in a dark place at room temperature.
  • do not shake bottles. Hold away from face when opening.

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified water

Princiapl Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrogen Peroxide

3% TOPICAL SOLUTION USP

FIRST AID ANTISEPTIC

TOPICAL ANTI-INFECTIVE FOR MINOR CUTS & ABRASIONS

ORAL DEBRIDING AGENT GARGLE OR RINSE

Distributed by: Kmart Corporation

Hoffman Estates , IL 60179

Shop kmart.com

call 1-800-842-7886

FL OZ (mL)

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

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

smart sense hydrogen peroxide 3%
smart sense hydrogen peroxide 3%

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 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49738-26849738-268-16, 49738-268-32

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 · 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
447e9553-7f89-4d3e-8064-2ffc9a176ef5ce31f6e2-888e-441d-8488-9c966afa7c382020-11-09WarningsExact identifier
spl id: 447e9553-7f89-4d3e-8064-2ffc9a176ef5
spl set id: ce31f6e2-888e-441d-8488-9c966afa7c38

Reported adverse events (FAERS/openFDA)#

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