Label: HISMILE STRAWBERRY FLAVOR ANTICAVITY- sodium fluoride paste, dentifrice
- NDC Code(s): 83013-308-06
- Packager: HISMILE PTY LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 15, 2023
If you are a consumer or patient please visit this version.
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- Drug Facts
- Active ingredient
- Purpose
- Use
- Warnings
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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 swallowing). • supervise children as necessary until capable of using without supervision. • children under 2 years of age: Consult a dentist or doctor.
- Other information
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Inactive ingredients
Water, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Disodium Phosphate, Flavor, Sodium Lauroyl Sarcosinate, Xanthan Gum, Cellulose Gum, Tetrapotassium Pyrophosphate, Caprylyl Glycol, Pentylene Glycol, Benzyl Alcohol, Sucralose, Methyl Diisopropyl Propionamide, Sodium Gluconate, Zinc Lactate, Benzoic Acid, D&C Red No.33.
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SPL UNCLASSIFIED SECTION
Manufactured for:
Hismile Pty Ltd, 225 Burleigh
Connection Rd, Burleigh Waters,
Queensland, Australia 4220.Formulated in Australia.
Made in Thailand.www.hismileteeth.com
© Hismile Pty Ltd, 2022TRUSTED BY DENTISTS
sugar-free
cruelty-free
no SLS & PEGs
vegan
Hismile uses the highest quality ingredients to provide a superior clean with oral health benefits. Paired with a refreshing burst of flavor, this toothpaste creates a unique smile care experience.
- Packaging
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INGREDIENTS AND APPEARANCE
HISMILE STRAWBERRY FLAVOR ANTICAVITY
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83013-308 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.4 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) XANTHAN GUM (UNII: TTV12P4NEE) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PENTYLENE GLYCOL (UNII: 50C1307PZG) BENZYL ALCOHOL (UNII: LKG8494WBH) SUCRALOSE (UNII: 96K6UQ3ZD4) METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489) SODIUM GLUCONATE (UNII: R6Q3791S76) ZINC LACTATE (UNII: 2GXR25858Y) BENZOIC ACID (UNII: 8SKN0B0MIM) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Product Characteristics Color Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83013-308-06 60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/14/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 06/14/2023 Labeler - HISMILE PTY LTD (758083252)
