FDA.reportPublic FDA data

Aplicare Hydrogen Peroxide

Manufacturer
Aplicare Products, LLC | Medline Industries, LP
Effective date
2023-10-18
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 23:56:59

Label at a glance#

ProductAplicare Hydrogen Peroxide
Active ingredientHYDROGEN PEROXIDE
Label structure10 sections

Dosage and administration

• apply locally as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen peroxide USP 3%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Use

INDICATIONS & USAGE SECTION

  • topical anti-infective

Warnings

WARNINGS SECTION

For external use only.

Avoid pooling beneath patient

Ask a doctor before use if injuries are

OTC - ASK DOCTOR SECTION

  • • deep or puncture wounds
  • • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • • infection occurs
  • • redness, irritation, swelling or pain persists or increases

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • • apply locally as needed

Other information

OTHER SAFETY INFORMATION

  • • not made with natural rubber latex
  • • protect from freezing, avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • water

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured by:

Aplicare Products, LLC.

550 Research Parkway, Meriden, CT 06450 USA

1-800-633-5463
0110

Recent Major Changes

RECENT MAJOR CHANGES SECTION

  • Indications and Usage
  • Warnings and Precautions
  • Dosage and Administration

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

frontfront

backback

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN9
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD9
91349hydrogen peroxide 3 % Topical SolutionSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52380-0013-1Aplicare Hydrogen Peroxide30 mL in 1 PACKETLIQUID309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52380-0013APLICARE HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) LIQUID [APLICARE PRODUCTS, LLC]9Legacy NDC, 1 package rows20231019_eca20774-4f35-448f-9e22-ad93d0e818c2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-0013-1ML - Milliliter52380-0013f923cd3a-05c1-4992-8cda-be97c9b3590512012-07-24

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 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52380-001352380-0013-1

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
080237a1-7924-ce26-e063-6294a90a9df4eca20774-4f35-448f-9e22-ad93d0e818c22023-10-18WarningsExact identifier
spl id: 080237a1-7924-ce26-e063-6294a90a9df4
spl set id: eca20774-4f35-448f-9e22-ad93d0e818c2

Reported adverse events (FAERS/openFDA)#

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