Pink Lemonade Flavor Sodium Fluoride Anticavity Toothpaste

Pink Lemonade Flavor Sodium Fluoride Anticavity Toothpast by

Drug Labeling and Warnings

Pink Lemonade Flavor Sodium Fluoride Anticavity Toothpast by is a Otc medication manufactured, distributed, or labeled by HISMILE PTY LTD, ACCUPAC LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PINK LEMONADE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPAST- sodium fluoride gel 
HISMILE PTY LTD

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Pink Lemonade Flavor Sodium Fluoride Anticavity Toothpaste

Active ingredient

Sodium Fluoride 0.24%

(0.14%w/v fluoride ion)

Purpose

Anticavity

Use

Use

Aids in the prevention of dental cavities

Warnings

Warnings

When using this product

When using this product Do not swallow

Do not use

Do not use in eye area

Keep out of reach of children

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

Directions

• Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal 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 seallowing).
• Supervise children as necessary until capable of using without supervision.
• Children under 2 years of age: Consult a dentist or doctor.

Inactive ingredients

Water

Sorbitol

Glycerin

Hydrated Silica

Xylitol

Flavor

Sodium Phosphate

Xanthan Gum

Sodium Lauroyl Sarcosinate

Sucralose

Tetrapotassium Pyrophosphate

1,2-Hexanediol

Cellulose Gum

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

D&C Red No. 33

label

PINK LEMONADE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPAST 
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83013-329
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.243 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM GLUCONATE (UNII: R6Q3791S76)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM PHOSPHATE (UNII: SE337SVY37)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
GLYCERIN (UNII: PDC6A3C0OX)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
XANTHAN GUM (UNII: TTV12P4NEE)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
ZINC LACTATE (UNII: 2GXR25858Y)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83013-329-06	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/19/2024	10/24/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	09/19/2024	10/24/2024

Labeler - HISMILE PTY LTD (758083252)

Establishment
Name	Address	ID/FEI	Business Operations
ACCUPAC LLC		061595175	manufacture(83013-329) , label(83013-329) , pack(83013-329)

Revised: 10/2024

Document Id: 253085aa-0d8a-bb51-e063-6294a90a9361

34390-5

Set id: 22749881-9f02-3f7d-e063-6294a90a6c52

Version: 2

Effective Time: 20241023