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NDC 73333-0115-01 Mint Dentistry 0.2938 g/113g Details

Mint Dentistry 0.2938 g/113g

Mint Dentistry is a ORAL PASTE in the HUMAN OTC DRUG category. It is labeled and distributed by Nutrix International, LLC.. The primary component is SODIUM FLUORIDE.

MedlinePlus Drug Summary

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 73333-0115-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	73333-0115
Product ID	73333-115_deaed4ba-c866-9d99-e053-2a95a90a9317
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Mint Dentistry
Proprietary Name Suffix	n/a
Non-Proprietary Name	Charcoal Spearmint
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE
Route	ORAL
Active Ingredient Strength	0.2938
Active Ingredient Units	g/113g
Substance Name	SODIUM FLUORIDE
Labeler Name	Nutrix International, LLC.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part355
Listing Certified Through	2023-12-31

Package

Package Images

NDC 73333-0115-01 (73333011501)

Pricing Information	N/A
NDC Package Code	73333-115-01
Billing NDC	73333011501
Package	113 g in 1 TUBE (73333-115-01)
Marketing Start Date	2020-04-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a382d2f5-be99-3bc5-e053-2995a90a1d19 Details

ACTIVE INGREDIENT

Sodium fluoride 0.24%

(0.15%w/v fluoride ion)

PURPOSE

Anticavity

INDICATIONS AND USAGE

Aids in the prevention of dental decay.

WARNING

As with all fluoride toothpaste, keep out of reach of children under 6 years old. If you accidentally swallow more than used for brushing, get medical help or call a Poison Control Center right away.

KEEP OUT OF REACH SECTION

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

DIRECTIONS

Adults and children 2 years and over: Brush teeth thoroughly after each meal or at least twice a day, or as directed by a dentist or doctor.

Children under 6 years of age: Use a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing). For children under 2 years of age: Ask a dentist or doctor.

INACTIVE INGREDIENTS

Glycerin, Sorbitol, Hydrated Silicas, Water (Aqua), Xylitol, Cocamidopropyl Betaine, Mentha Viridis (Spearmint) Leaf Oil, Stevia Rebaudiana Leaf /Steam Extract, Xanthan Gum, Activated Charcoal.

QUESTIONS?

Call 833.879.6468

Dosage and Administration

Use a pea-sized amount via oral

Package

INGREDIENTS AND APPEARANCE

MINT DENTISTRY

charcoal spearmint paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73333-115
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2938 g in 113 g

Ingredient Name	Strength
Inactive Ingredients
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)	0.3955 g in 113 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	23.73 g in 113 g
GLYCERIN (UNII: PDC6A3C0OX)	31.753 g in 113 g
WATER (UNII: 059QF0KO0R)	16.3285 g in 113 g
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	1.8532 g in 113 g
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)	0.565 g in 113 g
XYLITOL (UNII: VCQ006KQ1E)	11.3 g in 113 g
XANTHAN GUM (UNII: TTV12P4NEE)	0.452 g in 113 g
SPEARMINT OIL (UNII: C3M81465G5)	1.469 g in 113 g
SORBITOL (UNII: 506T60A25R)	24.86 g in 113 g

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73333-115-01	113 g in 1 TUBE; Type 0: Not a Combination Product	04/19/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	04/19/2020

Labeler - Nutrix International, LLC. (117341868)

Registrant - Nutrix International, LLC. (117341868)

Name	Address	ID/FEI	Business Operations
Establishment
Nutrix International, LLC		117341868	manufacture(73333-115) , pack(73333-115) , label(73333-115)

Revised: 5/2022

Document Id: deaed4ba-c866-9d99-e053-2a95a90a9317

Set id: a382d2f5-be99-3bc5-e053-2995a90a1d19

Version: 2

Effective Time: 20220510

Search by Drug Name or NDC

NDC 73333-0115-01 Mint Dentistry 0.2938 g/113g Details

Mint Dentistry 0.2938 g/113g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 73333-0115-01 (73333011501)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a382d2f5-be99-3bc5-e053-2995a90a1d19 Details

ACTIVE INGREDIENT

PURPOSE

INDICATIONS AND USAGE

WARNING

KEEP OUT OF REACH SECTION

DIRECTIONS

INACTIVE INGREDIENTS

QUESTIONS?

Dosage and Administration

Package

INGREDIENTS AND APPEARANCE

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