FDA.reportPublic FDA data

Ipana Bucky Beaver Bubble Gum Childrens Fluoride

Manufacturer
Maxill Inc | AmLion Toothpaste Sdn. Bhd
Effective date
2025-07-28
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:08:49

Label at a glance#

ProductIpana Bucky Beaver Bubble Gum Childrens Fluoride
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure7 sections

Dosage and administration

Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years: Consult a dentist or doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76% (Fluoride 0.1% w/w)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentaly swallowed get medical help or contact a Poison Control Center right away. external use only.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 years: Consult a dentist or doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

dicalcium phpsphate dihydrate, water, glycerin, hydrated silica, sorbitol, carboxymethylcellulose, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, sodium saccharin, sodium benzoate

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ipana

presents

Bucky Beaver

Bubble Gum

Children's Fluoride Toothpaste

NET WT. 0.66 OZ (19g)

ITEM 40510

Dist. by:

Maxill inc.

Cortland, OH, USA  44410

1-800-268-8633 www.maxill.com

Made in Malaysia

bubblegumlabelbubblegumlabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN9
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD9
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY9
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY9
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY9
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69510-020-19Ipana Bucky Beaver Bubble Gum Childrens Fluoride1 in 1 BOXPASTE19
69510-020-19Ipana Bucky Beaver Bubble Gum Childrens Fluoride19 g in 1 TUBEPASTE199

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56Q1
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEP1
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19X1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P91
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8Z1
SORBITOLINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69510-02069510-020-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XINJECTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPPASTE, DENTIFRICE / DENTAL51 %w/wExact identifier — unii+route
2 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE / DENTAL1.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XJELLY / VAGINALNAExact identifier — unii candidate
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM PYROPHOSPHATESODIUM PYROPHOSPHATEO352864B8ZPASTE, DENTIFRICE / DENTAL1 %w/wExact identifier — unii+route
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
16 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / DENTAL0.08 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XDROPS / ORAL10 mg/1mlExact identifier — unii candidate
16 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XDROPS / ORAL10 mg/1mlExact identifier — unii candidate
16 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / DENTAL0.3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XJELLY / VAGINALNAExact identifier — unii candidate
16 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XINJECTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
16 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XTABLET / ORAL45 mgExact identifier — unii candidate
16 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XSUSPENSION / ORAL50.07 mg/5mlExact identifier — unii candidate
16 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / DENTAL0.08 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XCAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
16 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPPASTE, DENTIFRICE / DENTAL51 %w/wExact identifier — unii+route
2 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE / DENTAL1.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM PYROPHOSPHATESODIUM PYROPHOSPHATEO352864B8ZPASTE, DENTIFRICE / DENTAL1 %w/wExact identifier — unii+route
2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XCAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
16 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XTABLET / ORAL45 mgExact identifier — unii candidate
16 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
16 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / DENTAL0.3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XSUSPENSION / ORAL50.07 mg/5mlExact identifier — unii candidate
16 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
16 equally ranked IID candidates

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
Ipana Bucky Beaver Bubble Gum Childrens FluorideSODIUM MONOFLUOROPHOSPHATEMaxill Ince7aa2a8d-7140-4718-bf69-917bb50d32c72025-07-28WarningsExact identifier
ndc (package): 69510-020-19
ndc (product): 69510-020
ndc11 (package): 69510002019
spl id: 3b02cda4-9b25-79c9-e063-6294a90af5b9
spl set id: e7aa2a8d-7140-4718-bf69-917bb50d32c7

Reported adverse events (FAERS/openFDA)#

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