FDA.reportPublic FDA data

HCS Hydrogen Peroxide 3%

Manufacturer
Concordance Healthcare Solutions, LLC. | Hydrox Chemical Company, Inc
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:32:50

Label at a glance#

ProductHCS Hydrogen Peroxide 3%
Active ingredientHydrogen Peroxide
Label structure8 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, mucous, or other secretions associated with occasional sore mouth

Dosage and administration

First aid antiseptic: - clean the affected area - apply a small amount of product on the area 1 to 3 times daily. - 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 the affected area for at least 1 minute and then spit out use up to 4 times daily afte...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide (stabilized) 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, mucous, 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 1 week

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

First aid antiseptic:

  • clean the affected area
  • apply a small amount of product on the area 1 to 3 times daily.
  • 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 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 dentist or doctor

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

Other information

OTHER SAFETY INFORMATION

Keep tightly closed in a cool dark place. Do not shake bottle. Hold away from face when opening.

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified water

Principal Display Panel – 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HCS

NDC 83506-001-16

Solution of
Hydrogen Peroxide
3% USP 10 Volume

FIRST AID ANTISEPTIC

ORAL DEBRIDING AGENT

  • For treatment of minor
    cuts, scrapes, and burns
  • For use as a gargle or rinse
  • For external use only

SEALED FOR YOUR PROTECTION

IF THE SEAL IS BROKEN OR MISSING DO NOT USE

16 FL OZ (1 PT) 473 mL

Principal Display Panel – 473 mL Bottle Label
Principal Display Panel – 473 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN12
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD12
91349hydrogen peroxide 3 % Topical SolutionSY12

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)00810132040252GTIN-14: 00810132040252
GTIN-12: 810132040252
UPC-A: 810132040252
EAN-13: 0810132040252
GTIN storage (14 digits): 00810132040252		hcs04-0002-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83506-001-042024-07-30C16284748780-11e7a6dab-1aae-a2ce-e063-dadaa90aadf7Hydrogen Peroxide Drug Facts
83506-001-042024-07-30C16284748780-11e7a6dab-1aae-a2ce-e063-dadaa90aadf7Hydrogen Peroxide Drug Facts
83506-001-082024-07-30C16284748780-11e7a6dab-1aae-a2ce-e063-dadaa90aadf7Hydrogen Peroxide Drug Facts
83506-001-082024-07-30C16284748780-11e7a6dab-1aae-a2ce-e063-dadaa90aadf7Hydrogen Peroxide Drug Facts
83506-001-162024-07-30C16284748780-11e7a6dab-1aae-a2ce-e063-dadaa90aadf7Hydrogen Peroxide Drug Facts
83506-001-162024-07-30C16284748780-11e7a6dab-1aae-a2ce-e063-dadaa90aadf7Hydrogen Peroxide Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83506-001-04HCS Hydrogen Peroxide 3%118 mL in 1 BOTTLE, PLASTICLIQUID11812
83506-001-08HCS Hydrogen Peroxide 3%237 mL in 1 BOTTLE, PLASTICLIQUID23712
83506-001-16HCS Hydrogen Peroxide 3%473 mL in 1 BOTTLE, PLASTICLIQUID47312

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
83506-00183506-001-04, 83506-001-08, 83506-001-16

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102024-11-26full-release2026-06-01 00:50:18

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
HCS Hydrogen Peroxide 3%HYDROGEN PEROXIDEConcordance Healthcare Solutions, LLC.f854ff4f-1327-4e2a-9389-591b01ba3ee22026-01-12WarningsExact identifier
ndc (package): 83506-001-08
ndc (package): 83506-001-16
ndc (package): 83506-001-04
ndc (product): 83506-001
ndc11 (package): 83506000104
ndc11 (package): 83506000116
ndc11 (package): 83506000108
spl id: 4da9c5aa-69bd-41bd-bb82-9efef32752bb
spl set id: f854ff4f-1327-4e2a-9389-591b01ba3ee2

Reported adverse events (FAERS/openFDA)#

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