Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID cea6f992-8a44-4eb8-baea-97b7b181b227
Route
ORAL
Published
Effective Date 2021-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg) Fluoride Ion (1.5 mg)
Inactive Ingredients
Water Hydrated Silica Sorbitol Glycerin Cocamidopropyl Betaine Sodium Cocoyl Glutamate Xanthan Gum Rebaudioside A Coconut Oil Aloe Vera Leaf Maltodextrin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-03

Description

Potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Purpose

Antihypersensitivity Anticavity


Medication Information

Purpose

Antihypersensitivity Anticavity

Description

Potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Uses
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
  • aids in the prevention of dental cavities.
Purposes

Antihypersensitivity

Anticavity

Warnings

When using this product,if irritation occurs discontinue use.

Directions
  • adults and children 12 years of age and older:
    • apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
    • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
  • Children under 12 years of age:Consult a dentist or doctor.
Other Information
  • do not store above 25°C (77F°)
Active Ingredients

Potassium nitrate 5%

Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Inactive Ingredients

water, hydrated silica, sorbitol, glycerin, flavor, cocamidopropyl betaine, sodium cocoyl glutamate, xanthan gum, rebaudioside A, cocos nucifera (coconut) oil, aloe barbadensis leaf extract, maltodextrin

Additional Information

ALWAYS FOLLOW THE LABEL

Natean was created by a small passionate team of scientists and herbalists on a mission to give you the best of what nature and science can offer, while minimizing our impact to the planet. Our toothpastes expertly balance powerful, scientifically studied ingredients with botanicals for a clean you can feel, and a clean you can feel good about.

NATEAN-INSPIRED BY NATURE AND DESIGNED TO BE CLEAN

RELIEVES SENSITIVE TEETH AND LEAVES YOUR MOUTH FEELING CLEAN AND FRESH

  • Infused with natural orange blossom and mint flavor, and extracts from aloe vera and coconut
  • Contains fluoride to fight cavities
  • Helps control tartar build-up with twice daily brushing

*No animal origin materials used in the processing of these products. Contains no animal ingredients or derivatives.

†Recycling facilities for this product may not exist in your area

BPA-FREE TUBE

Tube contains post consumer recycled plastic

Recycleable carton, tube & cap

Distributed by: Alacer Corp.Carlisle, PA 17013

© 2021 Alacer Corp.

www.nateantoothpaste.com

Questions Or Comments?

1-800-733-5879

Principal Display Panel

NDC 0135-1250-01

Natean

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NATURAL FLAVORS AND SWEETENERS

NON-GMO / GLUTEN-FREE

NO ARTIFICIAL PRESERVATIVES,

COLORS, DYES

NO SLS/TRICLOSAN

VEGAN-FRIENDLY*

INFUSED WITH

BOTANICALS

CLEAN + SENSITIVITY RELIEF

SOOTHING MINT

NET WT 4.7 OZ (133g)

1001587 Front Carton

Stop Use and Ask A Dentist If
  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use.

Structured Label Content

Uses
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
  • aids in the prevention of dental cavities.
Purposes

Antihypersensitivity

Anticavity

Warnings

When using this product,if irritation occurs discontinue use.

Directions
  • adults and children 12 years of age and older:
    • apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
    • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
  • Children under 12 years of age:Consult a dentist or doctor.
Other Information (Other information)
  • do not store above 25°C (77F°)
Active Ingredients (Active ingredients)

Potassium nitrate 5%

Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

water, hydrated silica, sorbitol, glycerin, flavor, cocamidopropyl betaine, sodium cocoyl glutamate, xanthan gum, rebaudioside A, cocos nucifera (coconut) oil, aloe barbadensis leaf extract, maltodextrin

Additional Information

ALWAYS FOLLOW THE LABEL

Natean was created by a small passionate team of scientists and herbalists on a mission to give you the best of what nature and science can offer, while minimizing our impact to the planet. Our toothpastes expertly balance powerful, scientifically studied ingredients with botanicals for a clean you can feel, and a clean you can feel good about.

NATEAN-INSPIRED BY NATURE AND DESIGNED TO BE CLEAN

RELIEVES SENSITIVE TEETH AND LEAVES YOUR MOUTH FEELING CLEAN AND FRESH

  • Infused with natural orange blossom and mint flavor, and extracts from aloe vera and coconut
  • Contains fluoride to fight cavities
  • Helps control tartar build-up with twice daily brushing

*No animal origin materials used in the processing of these products. Contains no animal ingredients or derivatives.

†Recycling facilities for this product may not exist in your area

BPA-FREE TUBE

Tube contains post consumer recycled plastic

Recycleable carton, tube & cap

Distributed by: Alacer Corp.Carlisle, PA 17013

© 2021 Alacer Corp.

www.nateantoothpaste.com

Questions Or Comments? (Questions or comments?)

1-800-733-5879

Principal Display Panel

NDC 0135-1250-01

Natean

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NATURAL FLAVORS AND SWEETENERS

NON-GMO / GLUTEN-FREE

NO ARTIFICIAL PRESERVATIVES,

COLORS, DYES

NO SLS/TRICLOSAN

VEGAN-FRIENDLY*

INFUSED WITH

BOTANICALS

CLEAN + SENSITIVITY RELIEF

SOOTHING MINT

NET WT 4.7 OZ (133g)

1001587 Front Carton

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)
  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use.

Advanced Ingredient Data


Raw Label Data

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