HISMILE by HISMILE PTY LTD

HISMILE by

Drug Labeling and Warnings

HISMILE by is a Otc medication manufactured, distributed, or labeled by HISMILE PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HISMILE- candy cane flavor sodium fluoride anticavity toothpaste gel 
HISMILE PTY LTD

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Candy Cane Flavor Sodium Fluoride Anticavity Toothpaste

Active ingredient

Sodium Fluoride 0.243%

(0.14 w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

When using this product

Do not swallow

Do not use in eye area

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

If more than used for brushing is swallowed, 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 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 of age: Consult a dentist or doctor.

Inactive ingredients

Water

Sorbitol

Hydrated Silica

Glycerin

Xylitol

Disodium Phosphate

Sucralose

Sodium Lauroyl Sarcosinate

Xanthan Gum

Cellulose Gum

Flavor

Tetrapotassium Pyrophosphate

Caprylyl Glycol

Benzyl Alcohol

Menthol

Sodium Gluconate

Pentylene Glycol

Zinc Lactate

Benzoic Acid

Methyl Diisopropyl Propionamide

Titanium Dioxide

label

HISMILE 
candy cane flavor sodium fluoride anticavity toothpaste gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83013-327
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
ZINC LACTATE (UNII: 2GXR25858Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
XYLITOL (UNII: VCQ006KQ1E)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
BENZOIC ACID (UNII: 8SKN0B0MIM)
MENTHOL (UNII: L7T10EIP3A)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM GLUCONATE (UNII: R6Q3791S76)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83013-327-01	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2024	11/19/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	07/23/2024	11/19/2024

Labeler - HISMILE PTY LTD (758083252)

Revised: 11/2024

Document Id: 273fd5c1-1a48-b4dd-e063-6394a90a3391

34390-5

Set id: 1e8f4f18-f1a6-81ac-e063-6294a90a6bdb

Version: 5

Effective Time: 20241119