FDA.reportPublic FDA data

Hydrogen Peroxide

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)
Effective date
2019-11-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:02:18

Label at a glance#

ProductHydrogen Peroxide 3 Percent
Active ingredientHYDROGEN PEROXIDE
Label structure10 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

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 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 use up to 4 times daily after meals and at bedti...

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) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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
  • 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
      • 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 bottle. Hold away from face when opening.

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified water

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Princiapl Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3% USP

Hydrogen Peroxide

First Aid Antiseptic

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

FL OZ (mL)

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 Quality Choice 3% Hydrogen PeroxideQuality Choice 3% Hydrogen Peroxide

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-926-16ML - Milliliter63868-926c9a7fe86-a76d-4351-80c5-2fd7435e373612014-08-01
63868-926-32ML - Milliliter63868-926198296c6-e38e-4d6e-b081-4ef34777564a12014-08-01

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
63868-92663868-926-08, 63868-926-16, 63868-926-32

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
7b0aaef6-1387-486a-bc1d-ffaa76617ee85b0bbceb-4b1f-40a3-aaba-422e65fa01172019-11-08WarningsExact identifier
spl id: 7b0aaef6-1387-486a-bc1d-ffaa76617ee8
spl set id: 5b0bbceb-4b1f-40a3-aaba-422e65fa0117

Reported adverse events (FAERS/openFDA)#

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