3% HYDROGEN PEROXIDE

Manufacturer
Universal Distribution Center LLC
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:23:37

Label at a glance#

Product3% HYDROGEN 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 an occasional sore mouth

Dosage and administration

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 • if bandaged, let dry first For use as an oral debriding agent (oral rinse) •  adults and children over 2 years of age :   • 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 no...

Storage and handling

• keep tightly closed and store at controlled room temperature. • do not shake the bottle. Hold away from face when opening.

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, mucus, or other secretions associated with an occasional sore mouth

Warnings

WARNINGS SECTION

For external use only.

When using this product • do not get into eyes • do not apply over large areas of the body • do not use longer than one week unless directed by a doctor

Ask a doctor before use if you have
• deep or 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.

Directions

DOSAGE & ADMINISTRATION SECTION

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 • if bandaged, let dry first

For use as an oral debriding agent (oral rinse)
• adults and children over 2 years of age:
  • 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

STORAGE AND HANDLING SECTION

• keep tightly closed and store at controlled room temperature.
• do not shake the bottle. Hold away from face when opening.

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified Water

SPL UNCLASSIFIED SECTION

For the Treatment of Minor Cuts and Abrasions

For Use as a Gargle or Rinse

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

Mfd for and Distributed by:
Universal Distribution Center LLC
330 Applegarth Road, Monroe Township,
NJ 08831

www.universaldc.com

“U” is a Registered Trademark of
Universal Distribution Center, LLC

Made in Turkey

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HydrogenperoxideHydrogenperoxide

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130676979560724GTIN-13: 0676979560724
EAN-13: 0676979560724
GTIN-12: 676979560724
UPC-A: 676979560724
GTIN storage (14 digits): 00676979560724
52000433-4.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-433-163% HYDROGEN PEROXIDE473 mL in 1 BOTTLE, PLASTICSOLUTION4731
52000-433-323% HYDROGEN PEROXIDE946 mL in 1 BOTTLE, PLASTICSOLUTION9461

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
52000-43352000-433-16, 52000-433-32

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
3% HYDROGEN PEROXIDEHYDROGEN PEROXIDEUniversal Distribution Center LLC53573a9c-bddc-49ea-931e-4779a20eb14f2025-12-15WarningsExact identifier
ndc (package): 52000-433-16
ndc (package): 52000-433-32
ndc (product): 52000-433
ndc11 (package): 52000043332
ndc11 (package): 52000043316
spl id: 7ba25357-af7c-440a-b7f5-3bb4877c3426
spl set id: 53573a9c-bddc-49ea-931e-4779a20eb14f

Reported adverse events (FAERS/openFDA)#

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