FDA.reportPublic FDA data

61010-5400, Hydrogen Peroxide spray

Manufacturer
Safetec of America, Inc.
Effective date
2024-02-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:08:35

Label at a glance#

ProductHydrogen Peroxide
Active ingredientHYDROGEN PEROXIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

spray over affected area if bandaged, let dry first

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide 3.0%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • near eyes or mucous membranes
  • on deep or puncture wounds, animal bites, or serious burns

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Caution

  • not for use on large areas of the body
  • if redness, irritation, swelling or pain persists or increases, discontinue use and consult a physician

Directions

DOSAGE & ADMINISTRATION SECTION

  • spray over affected area
  • if bandaged, let dry first

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water

PRINCIPAL DISPLAY PANEL – 2 oz. bottle label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-5400-2

Safetec

Hydrogen
Peroxide Spray

First Aid to Help
Prevent Infection in
Minor Cuts, Scrapes
and Burns.

2 fl. oz. (59.1ml)
Reorder no. 53001

PRINCIPAL DISPLAY PANEL – 2 oz. bottle label
PRINCIPAL DISPLAY PANEL – 2 oz. bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283420hydrogen peroxide 3 % Topical SprayPSN3
283420hydrogen peroxide 30 MG/ML Topical SpraySCD3
283420hydrogen peroxide 3 % Topical SpraySY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-5400-2Hydrogen Peroxide59.1 mL in 1 BOTTLE, SPRAYSPRAY59.13
61010-5400-4Hydrogen Peroxide118 mL in 1 BOTTLE, SPRAYSPRAY1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-5400HYDROGEN PEROXIDE SPRAY [SAFETEC OF AMERICA, INC.]3Current NDC, Legacy NDC, 2 package rows20240214_a665e2ce-c7e1-4d79-aa58-da7595944e7f.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#

Product NDC, Package NDC table
Product NDCPackage NDC
61010-540061010-5400-2, 61010-5400-4

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 · Source PDF

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 PEROXIDESafetec of America, Inc.a665e2ce-c7e1-4d79-aa58-da7595944e7f2024-02-07WarningsExact identifier
ndc (package): 61010-5400-4
ndc (package): 61010-5400-2
ndc (product): 61010-5400
ndc11 (package): 61010540004
ndc11 (package): 61010540002
spl id: 10d3b2a5-80d7-abe6-e063-6394a90aabf9
spl set id: a665e2ce-c7e1-4d79-aa58-da7595944e7f

Reported adverse events (FAERS/openFDA)#

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