Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 71b95962-2693-49f5-94d2-f2a035b5e0c8
Route
ORAL
Published
Effective Date 2021-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Water Hydrated Silica Sorbitol Glycerin Cocamidopropyl Betaine Sodium Cocoyl Glutamate Xanthan Gum Rebaudioside A Maltodextrin Bromelains Papain

Identifiers & Packaging

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

Description

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

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

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

Use
  • aids in the prevention of dental cavities.
Warnings

When using this product,if irritation occurs discontinue use.

Directions
  • adults and children 12 years of age and older:
    • brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as recommended by a dentist or doctor. Minimize swallowing. Spit out after brushing.
  • Children under 12 years of age:Consult a dentist or doctor
Active Ingredient

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

Other Information
  • do not store above 25°C (77F°)
Inactive Ingredients

water, hydrated silica, sorbitol, glycerin, cocamidopropyl betaine, sodium cocoyl glutamate, flavor, xanthan gum, rebaudioside A, maltodextrin, bromelain, papain

Additional Information

ALWAYS FOLLOW THE LABEL

*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

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

WHITENS TEETH AND LEAVES YOUR MOUTH FEELING CLEAN AND FRESH

  • Our blend with pineapple and papaya extracts, and silica removes stains and whitens teeth
  • Contains Fluoride to fight cavities
  • Helps control tartar build-up with twice daily brushing

BPA-FREE TUBE

Tube contains post consumer recycled plastic

Recycleable carton, tube & cap

Distributed by: Alacer Corp.Carlisle, PA 17013

Made in Taiwan © 2021 Alacer Corp.

www.nateantoothpaste.com

Questions Or Comments?

1-800-733-5879

Principal Display Panel

NDC 0135-1200-03

Natean

FLUORIDE TOOTHPASTE

NATURAL FLAVORS

AND SWEETENERS

NON-GMO / GLUTEN-FREE

NO ARTIFICIAL PRESERVATIVES,

COLORS, DYES

NO SLS/TRICLOSAN

VEGAN-FRIENDLY*

INFUSED WITH

BOTANICALS

FLUORIDE

CLEAN + WHITEN

CLEAN MINT

NET WT 4.7 OZ (133g)

60000000133573 Front Carton


Structured Label Content

Use
  • aids in the prevention of dental cavities.
Purpose

Anticavity

Warnings

When using this product,if irritation occurs discontinue use.

Directions
  • adults and children 12 years of age and older:
    • brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as recommended by a dentist or doctor. Minimize swallowing. Spit out after brushing.
  • Children under 12 years of age:Consult a dentist or doctor
Active Ingredient (Active ingredient)

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

Other Information (Other information)
  • do not store above 25°C (77F°)
Inactive Ingredients (Inactive ingredients)

water, hydrated silica, sorbitol, glycerin, cocamidopropyl betaine, sodium cocoyl glutamate, flavor, xanthan gum, rebaudioside A, maltodextrin, bromelain, papain

Additional Information

ALWAYS FOLLOW THE LABEL

*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

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

WHITENS TEETH AND LEAVES YOUR MOUTH FEELING CLEAN AND FRESH

  • Our blend with pineapple and papaya extracts, and silica removes stains and whitens teeth
  • Contains Fluoride to fight cavities
  • Helps control tartar build-up with twice daily brushing

BPA-FREE TUBE

Tube contains post consumer recycled plastic

Recycleable carton, tube & cap

Distributed by: Alacer Corp.Carlisle, PA 17013

Made in Taiwan © 2021 Alacer Corp.

www.nateantoothpaste.com

Questions Or Comments? (Questions or comments?)

1-800-733-5879

Principal Display Panel

NDC 0135-1200-03

Natean

FLUORIDE TOOTHPASTE

NATURAL FLAVORS

AND SWEETENERS

NON-GMO / GLUTEN-FREE

NO ARTIFICIAL PRESERVATIVES,

COLORS, DYES

NO SLS/TRICLOSAN

VEGAN-FRIENDLY*

INFUSED WITH

BOTANICALS

FLUORIDE

CLEAN + WHITEN

CLEAN MINT

NET WT 4.7 OZ (133g)

60000000133573 Front Carton


Advanced Ingredient Data


Raw Label Data

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