FDA.reportPublic FDA data

dentalux kids bubble gum

Manufacturer
Lidl US LLC
Effective date
2023-03-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:33:33

Label at a glance#

Productdentalux kids bubble gum
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Indications and uses

helps in the prevention of dental cavities

Dosage and administration

-Adults and children 2 years of age and olfer: brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentis or doctor do not swallow, to minimize swallowing, use a pea-sized amount in children under 6 years of age -teach children under 6 years of age good brushing and rinsing habits until capable of using without supervision - children under 2 years of age: consult a d...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

sodium fluoride 0.243% (0.15% w/v fluoride ion)

active ingredientactive ingredient

Purpose

OTC - PURPOSE SECTION

Anticavity

purposepurpose

Uses

INDICATIONS & USAGE SECTION

helps in the prevention of dental cavities

usesuses

Keep ot of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

warningswarnings

Warnings

WARNINGS SECTION

Keep out of reach of childre under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

warnings2warnings2

Directions

DOSAGE & ADMINISTRATION SECTION

-Adults and children 2 years of age and olfer: brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentis or doctor do not swallow, to minimize swallowing, use a pea-sized amount in children under 6 years of age

-teach children under 6 years of age good brushing and rinsing habits until capable of using without supervision

- children under 2 years of age: consult a dentist or a doctor

directionsdirections

inactive ingredients

INACTIVE INGREDIENT SECTION

sorbitol, hydrated silica, water propylene glycol, sodium C14-16 olefin sulfonate, cellulose gum, flavor, limonene, calcium glycerophosphate, soium saccharin, mica, FD&C blue 1, titanium dioxide

inactive ingredientsinactive ingredients

pdp

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71141-17271141-172-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
LIMONENE, (+)-GFD7C86Q1WIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
CALCIUM GLYCEROPHOSPHATEXWV9Z12C1CIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
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
f81f6d80-075b-16a6-e053-6294a90ab148c1e93abc-da80-f3e4-e053-2995a90af94e2023-03-30WarningsExact identifier
spl id: f81f6d80-075b-16a6-e053-6294a90ab148
spl set id: c1e93abc-da80-f3e4-e053-2995a90af94e

Reported adverse events (FAERS/openFDA)#

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