FDA.reportPublic FDA data

Medline Rinse

Manufacturer
Medline Industries, LP | Vi-Jon, Inc.
Effective date
2021-10-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:34:03

Label at a glance#

ProductMedline Rinse
Active ingredientHYDROGEN PEROXIDE
Label structure9 sections

Indications and uses

aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth for temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums for temporary use to cleanse canker sores assists in the removal of foreign material from minor oral wounds

Dosage and administration

adults and children 2 years of age and older: rinse two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician children under 12 should be supervised in the use of the product children under 2 years of age: consult a dentist or doctor

Storage and handling

store at controlled room temperature 68-77°F (20-25°C)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen peroxide 1.5%

Purpose

OTC - PURPOSE SECTION

Oral debriding agent/Oral wound cleanser

Uses

INDICATIONS & USAGE SECTION

  • aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth
  • for temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums
  • for temporary use to cleanse canker sores
  • assists in the removal of foreign material from minor oral wounds

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly

When using this product

OTC - WHEN USING SECTION

do not swallow

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: rinse two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out
  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician
  • children under 12 should be supervised in the use of the product
  • children under 2 years of age: consult a dentist or doctor

Other information

STORAGE AND HANDLING SECTION

store at controlled room temperature 68-77°F (20-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

blue 1, flavor, propylene glycol, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water

SPL UNCLASSIFIED SECTION

www.medline.com Manufactured for Medline Industries, Inc., Northfield, IL 60093 USA. Made in the USA with U.S. and Foreign Components. 1-800-MEDLINE

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 06Label 06Label 08Label 08Label 14Label 14

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
53329-14553329-145-14, 53329-145-08, 53329-145-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGEN PEROXIDEBBX060AN9VACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLOXAMER 338F75JV2T505IACT
POLYSORBATE 207T1F30V5YHIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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
cf2f41b4-f6dc-1fe3-e053-2a95a90afe199a259617-3fd4-5d99-e053-2a95a90a1f1b2021-10-25WarningsExact identifier
spl set id: 9a259617-3fd4-5d99-e053-2a95a90a1f1b

Reported adverse events (FAERS/openFDA)#

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