FDA.reportPublic FDA data

Quality Guaranteed Hydrogen Peroxide Solution

Manufacturer
Worldwide Sales & Distribution Corp. | Steller Mercantile Pvt. Ltd.
Effective date
2011-08-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:29:21

Label at a glance#

ProductHydrogen Peroxide
Active ingredientHYDROGEN PEROXIDE
Label structure8 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Hydrogen peroxide 3%

OTC - PURPOSE SECTION

Purpose
First aid antiseptic
Oral debriding agent

INDICATIONS & USAGE SECTION

Uses
  • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
  • aid in the removal of phlegm, mucus or other secretions associated with occasional sore mouth

WARNINGS SECTION

Warnings
For external use only

OTC - DO NOT USE SECTION

Do not use
  • in the eyes or apply over large areas of the body
  • more than one week

OTC - ASK DOCTOR SECTION

Consult a doctor before use if you have animal bites or serious burns, deep or punctured wounds

OTC - STOP USE SECTION

Stop use and ask a doctor if
  • the condition persists or gets worse
  • sore mouth symptoms do not improve in a week
  • pain redness or irritation persists or if you develop fever, rash or swelling

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children
If swallowed seek professional assistance or contact a poison control center immediately

DOSAGE & ADMINISTRATION SECTION

Directions
First aid antiseptic
•clean the affected area
•apply a small amount of product on the affected area 1 to 3 times a day
•may be covered with a sterile bandage
•let dry first before using bandage

Oral debriding agent (oral rinse)
Adults and children 2 years of age and over:
• mix with 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 doctor or dentist

• children under 2 years of age: consult a dentist or doctor
• children under 12 years of age should be supervised in the use of this product

GENERAL PRECAUTIONS SECTION

Other information
Keep tightly closed in a dark place at controlled room temperature
Do not shake bottle. Keep away from face when opening

INACTIVE INGREDIENT SECTION

Inactive ingredient
Purified water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of principal display panelimage of principal display panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN1
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD1
91349hydrogen peroxide 3 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76384-007-012019-10-29C16284748780-1960f7f55-d4f3-8e05-e053-dbdaa90a074aQuality Guaranteed Hydrogen Peroxide Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76384-007-01Hydrogen Peroxide.473 L in 1 BOTTLE, PLASTICSOLUTION.4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76384-007HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) SOLUTION [WORLDWIDE SALES & DISTRIBUTION CORP.]1Legacy NDC, 1 package rows20110829_c6603207-82aa-4bcc-9ed7-b4208db83a3c.zip

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 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76384-00776384-007-01

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
e853c662-f640-481a-866c-35e1aebe957dc6603207-82aa-4bcc-9ed7-b4208db83a3c2011-08-25WarningsExact identifier
spl id: e853c662-f640-481a-866c-35e1aebe957d
spl set id: c6603207-82aa-4bcc-9ed7-b4208db83a3c

Reported adverse events (FAERS/openFDA)#

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