FDA.reportPublic FDA data

Hydrogen Peroxide 3%

Manufacturer
4 Visions LLC
Effective date
2026-02-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:46:57

Label at a glance#

ProductHydrogen Peroxide 3%
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 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 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 & 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 ...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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 removal of phlegm, mucous, or other secretions associated with occasional sore mouth

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • 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 havedeep 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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

First Aid Antiseptic
  • clean the affected area
  • apply a small amount of product on the area 1 to 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 & 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

STORAGE AND HANDLING SECTION

  • 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 One Gallon

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 87251-002-99

REF: 613-1172

epic medical supply

Solution of

Hydrogen Peroxide

3% USP 10 Volume

First Aid Antiseptic

Tamper evident cap for your protection. If ring band is detatche or missing do not use.

One Gallon (3.8L)

Made in USA

Manufactured for:

4 Visions LLC

Lakewood, NJ 08701

www.epicmedsupply.com

labellabel

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-130850042015049GTIN-13: 0850042015049
EAN-13: 0850042015049
GTIN-12: 850042015049
UPC-A: 850042015049
GTIN storage (14 digits): 00850042015049		613-1172 Label.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
87251-002-16Hydrogen Peroxide 3%473 mL in 1 BOTTLE, PLASTICSOLUTION4731
87251-002-32Hydrogen Peroxide 3%946 mL in 1 BOTTLE, PLASTICSOLUTION9461
87251-002-99Hydrogen Peroxide 3%3785 mL in 1 BOTTLE, PLASTICSOLUTION37851

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
87251-00287251-002-16, 87251-002-99, 87251-002-32

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
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VACTIB

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
Hydrogen Peroxide 3%HYDROGEN PEROXIDE 3%4 Visions LLC4b87254a-8dc5-3873-e063-6394a90a3f3b2026-02-23WarningsExact identifier
ndc (package): 87251-002-32
ndc (package): 87251-002-99
ndc (package): 87251-002-16
ndc (product): 87251-002
ndc11 (package): 87251000216
ndc11 (package): 87251000299
ndc11 (package): 87251000232
spl id: 4b872cde-2f10-fb4e-e063-6294a90ab028
spl set id: 4b87254a-8dc5-3873-e063-6394a90a3f3b

Reported adverse events (FAERS/openFDA)#

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