hismile PEACH ICED TEA FLAVOR anticavity

hismile PEACH ICED TEA FLAVOR anticavity by

Drug Labeling and Warnings

hismile PEACH ICED TEA FLAVOR anticavity by is a Otc medication manufactured, distributed, or labeled by HISMILE PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HISMILE PEACH ICED TEA FLAVOR ANTICAVITY- sodium fluoride paste, dentifrice 
HISMILE PTY LTD

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.

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 hismile PEACH ICED TEA FLAVOR anticavity

Drug Facts

Active ingredient

Sodium Fluoride 0.24%
(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 reach of children under 6 years of age. If more than used for brushing is accidentally 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 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

store in a cool, dry place.

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.

Questions or comments?

+1-302-440-3558
You may also report serious side effects to this phone number.

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, 2022

TRUSTED 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

HISMILE PEACH ICED TEA FLAVOR ANTICAVITY 
sodium fluoride paste, dentifrice

Product 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)

Revised: 10/2022

Document Id: db9b38ed-f3aa-467b-be0c-fc58e0ae981f

34390-5

Set id: c0caaae1-e672-4441-934d-81634fd254fb

Version: 1

Effective Time: 20221014