FDA.reportPublic FDA data

G.U.M

Manufacturer
Sunstar Guangzhou Ltd.
Effective date
2020-02-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:40:03

Label at a glance#

ProductG.U.M
Active ingredientCETYLPYRIDINIUM CHLORIDE, SODIUM FLUORIDE
Label structure8 sections

Dosage and administration

Adults and children 6 years of age and older:brush teeth thoroughly, after meals or at least twice a day or use as directed by a dentist. do not swallow to minimize swallowing use a pea-sized amount in children under 6 supervise children's burshing ntil good habits are established children under 2 years ask a dentist

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

SODIUM FLUORIDE 0.21%

CETYLPYRIDINIUM CHLORIDE 0.5%

Purpose

OTC - PURPOSE SECTION

Anticavitytoothpaste

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental decay

Warning

WARNINGS SECTION

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidently swallowed get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older:brush teeth thoroughly, after meals or at least twice a day or use as directed by a dentist.

do not swallow

to minimize swallowing use a pea-sized amount in children under 6

supervise children's burshing ntil good habits are established

children under 2 years ask a dentist

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER,SORBITOL,XANTHAN GUM,SODIUM SILICATE,TRIPOTASSIUM GLYCYRRHIZINATE,PROPYLENE GLYCOL DIACETATE,SODIUM LAURYL SULFATE,CELLULOSE ACETATE,TITANIUM DIOXIDE,CETYLPYRIDINIUM CHLORIDE,SACCHARIN SODIUM,CETYL HYDROXYETHYLCELLULOSE (350000 MW),GLYCERIN

Keep out of reach of children under 6 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53050-00253050-002-01, 53050-002-02, 53050-002-03, 53050-002-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL HYDROXYETHYLCELLULOSE (350000 MW)T7SWE4S2TTIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM SILICATEIJF18F77L3IACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL DIACETATE5Z492UNF9OIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CELLULOSE ACETATE3J2P07GVB6IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIPOTASSIUM GLYCYRRHIZINATELD4YKZ48B6IACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
9fa4887f-7c0c-1461-e053-2995a90a9e114b537e5c-367f-17d3-e054-00144ff88e882020-02-28WarningsExact identifier
spl id: 9fa4887f-7c0c-1461-e053-2995a90a9e11
spl set id: 4b537e5c-367f-17d3-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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