Label: HISMILE- strawberry flavor sodium fluoride anticavity toothpaste gel
- NDC Code(s): 83013-318-06
- Packager: Hismile Pty Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 15, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warinings
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Directions
- adults and children 2 years of ange 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.
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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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Other information
Strawberry Flavor Sodium Fluoride Anticavity Toothpaste
Manufactured for:
Hismile Pty Ltd, 225 Burleigh
Connection Rd, Burleigh Waters,
Queensland, Australia 4220.Formulated in Australia.
Made in USA.www.hismileteeth.com
© Hismile Pty Ltd, 2022TRUSTED BY DENTISTS
sugar-free
cruelty- free
no SLS & PEGs
veganHismile 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.
- label
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INGREDIENTS AND APPEARANCE
HISMILE
strawberry flavor sodium fluoride anticavity toothpaste gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83013-318 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 D&C RED NO. 33 (UNII: 9DBA0SBB0L) WATER (UNII: 059QF0KO0R) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PENTYLENE GLYCOL (UNII: 50C1307PZG) METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SORBITOL (UNII: 506T60A25R) ZINC LACTATE (UNII: 2GXR25858Y) XANTHAN GUM (UNII: TTV12P4NEE) BENZYL ALCOHOL (UNII: LKG8494WBH) BENZOIC ACID (UNII: 8SKN0B0MIM) SUCRALOSE (UNII: 96K6UQ3ZD4) XYLITOL (UNII: VCQ006KQ1E) POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G) SODIUM GLUCONATE (UNII: R6Q3791S76) Product Characteristics Color Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83013-318-06 60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/15/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 01/15/2024 Labeler - Hismile Pty Ltd (758083252) Establishment Name Address ID/FEI Business Operations Accupac, LLC 061595175 manufacture(83013-318)
