FDA.reportPublic FDA data

MedPak Peroxide Oral Rinse

Manufacturer
Elba, Inc.
Effective date
2021-05-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:45:05

Label at a glance#

ProductMedPak Peroxide Oral Rinse
Active ingredientHYDROGEN PEROXIDE
Label structure8 sections

Indications and uses

Aids in the romoval of phlegm, mucus, or other secretions in the temporary relief of discomfort due to occasional sore throat and sore mouth.

Dosage and administration

Topical dosage for adults and children 3 years of age and older is a rinse used no more than 4 times daily. For children under 3 years of age, there is no recommended dosage except under the advice and supervision of a dentist or doctor. Use only under health care practitioners supervision.

Label contents#

Full prescribing information#

Active Ingredinet:

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide 1.5%

Purpose

OTC - PURPOSE SECTION

Oral Debriding Agent

Uses

INDICATIONS & USAGE SECTION

  • Aids in the romoval of phlegm, mucus, or other secretions in the temporary relief of discomfort due to occasional sore throat and sore mouth.

Warning

WARNINGS SECTION

Stop use and ask doctor if:

OTC - STOP USE SECTION

  • Swelling, rash, or fever develop.
  • Severe or persistent sure throat or sore throat accompanied by high feverm headache, annsea, and vomiting occurs.

Do not use 

OTC - DO NOT USE SECTION

more than 2 days or administer to children under 3 years of age unless directed by a physician.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

under 3 years of age.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Topical dosage for adults and children 3 years of age and older is a rinse used no more than 4 times daily. For children under 3 years of age, there is no recommended dosage except under the advice and supervision of a dentist or doctor.
  • Use only under health care practitioners supervision.

Other Information

SPL UNCLASSIFIED SECTION

  • Store at room temperature.

Avoid excessive heat. Avoid freezing.

Inactive Ingredinets

INACTIVE INGREDIENT SECTION

Purified Water, Glycerin, Flavor, Sodium Saccharin, Sorbitol, Polysorbate 20, Cetylpyridium Chloride, D&C Green #5

Questions or Comments?

OTC - QUESTIONS SECTION

1-248-288-6098

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLidLid

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10031-00810031-008-07

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
POLYSORBATE 207T1F30V5YHIACT
CETYLPYRIDINIUMCUB7JI0JV3IACT
CHLORIDAZON26X5RK7X7WIACT
D&C GREEN NO. 58J6RDU8L9XIACT
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
c1fda82a-2cff-2bc8-e053-2a95a90af4bf4b2a349b-93ba-5ef5-e054-00144ff8d46c2021-05-10WarningsExact identifier
spl id: c1fda82a-2cff-2bc8-e053-2a95a90af4bf
spl set id: 4b2a349b-93ba-5ef5-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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