FDA.reportPublic FDA data

MEDI-FIRST First Aid Antiseptic

Manufacturer
Ultra Distributors Inc
Effective date
2025-04-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:58:47

Label at a glance#

ProductMEDI-FIRST First Aid Antiseptic
Active ingredientHYDROGEN PEROXIDE
Label structure12 sections

Indications and uses

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

Dosage and administration

spray over a affected area if bandaged, let dry first not to be used on children under 12 years of age

Label contents#

Full prescribing information#

Active ingredient

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 consult a doctor
  • on large areas of the body

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • spray over a affected area
  • if bandaged, let dry first
  • not to be used on children under 12 years of age

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-634-7680

SPL UNCLASSIFIED SECTION

Treats minor cuts, scrapes and abrasions

Helps prevent infection

Store at 68°-77°F(20°-25°℃)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of bottle labelimage of bottle label

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78495-162-012025-04-07C16284748780-12cef2736-9db8-d83d-e063-dadaa90ab31f78495-162
78495-162-012025-01-30C16284748780-12cef2736-9db8-d83d-e063-dadaa90ab31f78495-162

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78495-162-01MEDI-FIRST First Aid Antiseptic0.0591 L in 1 BOTTLE, PUMPSPRAY0.05912

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78495-162MEDI-FIRST FIRST AID ANTISEPTIC (HYDROGEN PEROXIDE) SPRAY [ULTRA DISTRIBUTORS INC]2Current NDC, Legacy NDC, 1 package rows20250409_b6f7b346-3d6b-5953-e053-2995a90a878f.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
78495-16278495-162-01

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
MEDI-FIRST First Aid AntisepticHYDROGEN PEROXIDEUltra Distributors Incb6f7b346-3d6b-5953-e053-2995a90a878f2025-04-07WarningsExact identifier
ndc (package): 78495-162-01
ndc (product): 78495-162
ndc11 (package): 78495016201
spl id: 32399f44-cad6-b53f-e063-6394a90aafb5
spl set id: b6f7b346-3d6b-5953-e053-2995a90a878f