Label: HISMILE PEACH ICED TEA FLAVOR ANTICAVITY- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 83013-301-06 - 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 October 14, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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, Flavor, Disodium Phosphate, Sodium Lauroyl Sarcosinate, Calcium Glycerophosphate, Cellulose Gum, Xanthan Gum, Tetrapotassium Pyrophosphate, Benzyl Alcohol, Caprylyl Glycol, Sucralose, Menthol, Sodium Gluconate, Pentylene Glycol, Zinc Lactate, Methyl Diisopropyl Propionamide, Benzoic Acid.
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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
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.
- Packaging
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INGREDIENTS AND APPEARANCE
HISMILE PEACH ICED TEA FLAVOR ANTICAVITY
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83013-301 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) CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) XANTHAN GUM (UNII: TTV12P4NEE) POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G) BENZYL ALCOHOL (UNII: LKG8494WBH) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SUCRALOSE (UNII: 96K6UQ3ZD4) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) SODIUM GLUCONATE (UNII: R6Q3791S76) PENTYLENE GLYCOL (UNII: 50C1307PZG) ZINC LACTATE (UNII: 2GXR25858Y) METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489) BENZOIC ACID (UNII: 8SKN0B0MIM) Product Characteristics Color Score Shape Size Flavor PEACH (peach iced tea) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83013-301-06 60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 12/09/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 12/09/2022 Labeler - HISMILE PTY LTD (758083252)
