FDA.reportPublic FDA data

Hydrogen Peroxide

Manufacturer
Trifecta Pharmaceuticals USA, LLC.
Effective date
2024-01-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:27

Label at a glance#

ProductHydrogen Peroxide
Active ingredientHYDROGEN PEROXIDE
Label structure12 sections

Dosage and administration

Spray over affected area If bandaged, let dry first Not to be used on children under 12 years of age

Storage and handling

Store at controlled room temperature 68º-77ºF (20º-25ºC)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide 3.0%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

INDICATIONS & USAGE SECTION

First Aid to help prevent infection in minor cuts, scrapes, and burns.

Warnings

WARNINGS SECTION

For External Use Only

Stop use and ask a doctor

OTC - STOP USE SECTION

  • If the condition persists or gets worse. Do not use longer than 1 week unlesss directed by a doctor.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • Spray over affected area
  • If bandaged, let dry first
  • Not to be used on children under 12 years of age

Other information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 68º-77ºF (20º-25ºC)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-888-296-9067

Distributed By:

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

SKU: 4069-FBA

Made in China

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4069 Globe Hydrogen Peroxide Spray 2oz Rev10 060922 CDER4069 Globe Hydrogen Peroxide Spray 2oz Rev10 060922 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283420hydrogen peroxide 3 % Topical SprayPSN2
283420hydrogen peroxide 30 MG/ML Topical SpraySCD2
283420hydrogen peroxide 3 % Topical SpraySY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-108-02Hydrogen Peroxide0.059 L in 1 BOTTLE, SPRAYSPRAY0.0592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-108HYDROGEN PEROXIDE (HYDROGEN PEROXIDE 3.0%) SPRAY [TRIFECTA PHARMACEUTICALS USA, LLC.]2Current NDC, Legacy NDC, 1 package rows20240103_e4e45f11-7cd4-e693-e053-2a95a90a4c34.zip

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
69396-10869396-108-02

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 PeroxideHYDROGEN PEROXIDE 3.0%Trifecta Pharmaceuticals USA, LLC.e4e45f11-7cd4-e693-e053-2a95a90a4c342024-01-02WarningsExact identifier
ndc (package): 69396-108-02
ndc (product): 69396-108
ndc11 (package): 69396010802
spl id: 0df88ec4-4620-1282-e063-6394a90a5a3d
spl set id: e4e45f11-7cd4-e693-e053-2a95a90a4c34

Reported adverse events (FAERS/openFDA)#

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