Hydrogen peroxide Topical Solution USP 3%

Manufacturer
Universal Distribution Center LLC | BIOTEK INDIA
Effective date
2020-10-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:32:21

Label at a glance#

ProductHydrogen Peroxide
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

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 • in the eyes or apply over large areas of the body • longer than one week

Ask a doctor before use if you have • deep puncture wounds, animal bites or serious burns

Stop use and ask a doctor if • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Directions For use 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 bandage, 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 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

SPL UNCLASSIFIED SECTION

Topical Solution USP 3%

First Aid Antiseptic/Oral Debriding Agent

For Treatment of Minor Cuts & Abrasions

For Use As a Gargle or Rinse

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

Distributed by:

Universal Distribution Center

96 Distribution Boulevard

Edison, NJ 08817

Made in India

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN2
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD2
91349hydrogen peroxide 3 % Topical SolutionSY2

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
52000-025-032022-07-29C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-062022-07-29C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-072022-07-29C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-312022-07-29C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-322022-07-29C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-402022-07-29C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-412022-07-29C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-422022-07-29C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-432022-07-29C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-442022-07-29C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-452022-07-29C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-032020-10-23C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-062020-10-23C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-072020-10-23C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-312020-10-23C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-322020-10-23C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-402020-10-23C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-412020-10-23C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-422020-10-23C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-432020-10-23C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-442020-10-23C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-452020-10-23C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-032020-01-31C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-062020-01-31C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-072020-01-31C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-312020-01-31C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-322020-01-31C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-402020-01-31C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-412020-01-31C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-422020-01-31C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-432020-01-31C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-442020-01-31C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%
52000-025-452020-01-31C16284748780-19d75b9d0-d678-f424-e053-dadaa90a57ceHydrogen peroxide Topical Solution USP 3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-025-03Hydrogen Peroxide237 mL in 1 BOTTLE, PLASTICLIQUID2372
52000-025-06Hydrogen Peroxide414 mL in 1 BOTTLE, PLASTICLIQUID4142
52000-025-07Hydrogen Peroxide473 mL in 1 BOTTLE, PLASTICLIQUID4732
52000-025-31Hydrogen Peroxide295 mL in 1 BOTTLE, PLASTICLIQUID2952
52000-025-32Hydrogen Peroxide354 mL in 1 BOTTLE, PLASTICLIQUID3542
52000-025-40Hydrogen Peroxide100 mL in 1 BOTTLE, PLASTICLIQUID1002
52000-025-41Hydrogen Peroxide119 mL in 1 BOTTLE, PLASTICLIQUID1192
52000-025-42Hydrogen Peroxide178 mL in 1 BOTTLE, PLASTICLIQUID1782
52000-025-43Hydrogen Peroxide200 mL in 1 BOTTLE, PLASTICLIQUID2002
52000-025-44Hydrogen Peroxide250 mL in 1 BOTTLE, PLASTICLIQUID2502
52000-025-45Hydrogen Peroxide266 mL in 1 BOTTLE, PLASTICLIQUID2662

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-025HYDROGEN PEROXIDE LIQUID [UNIVERSAL DISTRIBUTION CENTER LLC]2Legacy NDC, 11 package rows20201024_091bea0c-7582-45d7-b04e-7d49d7fc4648.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#

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
06c02867-b655-4fa4-898c-f0bb56487981091bea0c-7582-45d7-b04e-7d49d7fc46482020-10-22WarningsExact identifier
spl id: 06c02867-b655-4fa4-898c-f0bb56487981
spl set id: 091bea0c-7582-45d7-b04e-7d49d7fc4648

Reported adverse events (FAERS/openFDA)#

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