PerioRinse

Manufacturer
CENTURA PHARMACEUTICALS INC
Effective date
2016-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:26:02

Label at a glance#

ProductPerioRinse
Active ingredientDYCLONINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

For the temporary relief of occasional minor irritation,pain,sore mouth,and sore throat.

Dosage and administration

• Children 3-12 years of age - Vigorously swish and spit with 5ml to 10ml (1 to 2 teaspoonful’s) not more than three to four times a day. Try to avoid swallowing. • Adults and children over 12 years of age - Vigorously swish and spit with 10ml to 20ml (2 to 4 teaspoonful’s) not more than three to four times a day. Try to avoid swallowing.

Storage and handling

• Store at room temperature.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Dyclonine 0.10%

PURPOSE

OTC - PURPOSE SECTION

Anesthetic/Analgesic

USES

INDICATIONS & USAGE SECTION

For the temporary relief of occasional minor irritation,pain,sore mouth,and sore throat.

WARNINGS

WARNINGS SECTION

• Severe or persistent sore throat or sore throat accompanied by high fever, headache,
nausea, and vomiting may be serious. Consult dentist or doctor promptly.
• Do not use more than 2 days or administer to children under 3 years of age unless
directed by a dentist or doctor.
• Discontinue use and consult a dentist or doctor if irritation persists or increases, or
a rash appears or you are allergic to this product.
• Try to avoid swallowing this product.
• If large quantity is accidentally swallowed, get medical help or contact a Poison
Control Center right away.
• Keep out of reach of children.
• If pregnant or breast-feeding, consult a dentist or doctor before use.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• Children 3-12 years of age - Vigorously swish and spit with 5ml to 10ml (1 to 2
teaspoonful’s) not more than three to four times a day. Try to avoid swallowing.
• Adults and children over 12 years of age - Vigorously swish and spit with 10ml to 20ml
(2 to 4 teaspoonful’s) not more than three to four times a day. Try to avoid swallowing.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

• Store at room temperature.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Glycerin, Glycyrrhiza Glabra (Licorice)
Extract, Hydrastis Canadensis (Golden Seal) Extract, Cherry Flavor, Potassium Sorbate,
Sodium Benzoate, Stevia.

PACKAGE LABELING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70372-726-012020-02-08C16284748780-19d75b9d0-40b1-f424-e053-dadaa90a57ce34385375-1c3d-5ecd-e054-00144ff8d46c
70372-726-012020-01-31C16284748780-19d75b9d0-40b1-f424-e053-dadaa90a57ce34385375-1c3d-5ecd-e054-00144ff8d46c

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70372-72670372-726-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
34385375-1c3e-5ecd-e054-00144ff8d46c34385375-1c3d-5ecd-e054-00144ff8d46c2016-06-01WarningsExact identifier
spl id: 34385375-1c3e-5ecd-e054-00144ff8d46c
spl set id: 34385375-1c3d-5ecd-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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