ALBOTHYL

Manufacturer
Lydia Co., Ltd.
Effective date
2023-07-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:55:56

Label at a glance#

ProductALBOTHYL
Active ingredientPOLICRESULEN
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Policresulen Solution

OTC - PURPOSE SECTION

Oral debriding agent/oral wound cleanser for temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums such as mouth burns, cheek bites and toothbrush abrasions. Cleans minor mouth wounds by removing foreign materials that can impede the healing process

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Adults and children 2 years of age and older: rinse half of a capful around in the mouth over affected area 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 years of age should be supervised in the use of the product. Children under 2 years of age: consult a dentist or physician. To open child safety cap, squeeze smooth sides while turning. Reclose tightly

WARNINGS SECTION

Do not use this product for more than 7 days unless directed by a dentist or physician.

When using this product, do not swallow.

Stop use and ask a doctor if. Sore mouth symptoms do not improve within 7 days. Irritation, pain or redness persists or worsens. Swelling, rash or fever develops.

Keep out of reach of children.

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

Do not use if carton is opened. Do not use if printed band on bottle is broken or missing

INACTIVE INGREDIENT SECTION

Water; Sorbitol; Propylene Glycol; Poloxamer

DOSAGE & ADMINISTRATION SECTION

for oral use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72988-0035-1ALBOTHYL5 g in 1 BOTTLELIQUID53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72988-0035ALBOTHYL (POLICRESULEN SOLUTION) LIQUID [LYDIA CO., LTD.]3Current NDC, 1 package rows20230819_f2ea4e1b-a3d7-d063-e053-2a95a90a6d0b.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72988-003572988-0035-1

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
POLICRESULEN6I19M5GB0GACTIB

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
ALBOTHYLPOLICRESULEN SOLUTIONLydia Co., Ltd.f2ea4e1b-a3d7-d063-e053-2a95a90a6d0b2023-07-10WarningsExact identifier
ndc (package): 72988-0035-1
ndc (product): 72988-0035
ndc11 (package): 72988003501
spl id: 001d54ef-148b-e55a-e063-6294a90a7c40
spl set id: f2ea4e1b-a3d7-d063-e053-2a95a90a6d0b

Reported adverse events (FAERS/openFDA)#

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