FDA.reportPublic FDA data

983 Curad Hydrogen Peroxide Solution

Manufacturer
Medline Industries, LP
Effective date
2022-12-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:44:09

Label at a glance#

ProductCURAD Hydrogen Peroxide
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 the removal of phlegm, mucus, 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 affected area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first Oral debriding agent: adults, children over 2 years of age: mix with an equal amount of water swish around in the mouth over the affected area for at least 1 minute, then spit out use up to 4 times daily after meals and at bedtime chi...

Storage and handling

keep tightly closed and at controlled room temperature. Do not shake bottle. Hold away from face when opening.

Label contents#

Full prescribing information#

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

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in the eyes or apply over large areas of the body
  • longer than 1 week

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

deep or puncture wounds, animal bites or serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

First aid antiseptic:

  • clean the affected area
  • apply a small amount of product on the affected area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Oral debriding agent:

adults, children over 2 years of age:

  • mix with an equal amount of water
  • swish around in the mouth over the affected area for at least 1 minute, then spit out
  • use up to 4 times daily after meals and at bedtime
  • children under 12 years of age should be supervised in the use.
  • children under 2 years of age: consult a dentist, doctor

Other information

STORAGE AND HANDLING SECTION

keep tightly closed and at controlled room temperature. Do not shake bottle. Hold away from face when opening.

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified water

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for:
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Made in USA with domestic and foreign materials
www.curad.com
1-800-633-5463
REF: L0012528
RB12VJO

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CURAD Hydrogen Peroxide 3% labelCURAD Hydrogen Peroxide 3% label CURAD

NDC 53329-983-23

HYDROGEN PEROXIDE 3%

Topical Solution USP

First Aid Antiseptic

Oral Debriding Agent

  • For treatment of minor cuts and abrasions

32 FL OZ (946 mL)

Do not use if printed seal under cap is broken or missing

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
53329-98353329-983-06, 53329-983-23

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
030f8be6-df60-8128-e063-6394a90a3da20bf4c68b-9244-4a1d-9555-04a07e3f84672023-08-16WarningsExact identifier
spl set id: 0bf4c68b-9244-4a1d-9555-04a07e3f8467

Reported adverse events (FAERS/openFDA)#

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