Tanners Sodium Fluoride Tooth Paste

Tanners Sodium Fluoride Tooth Paste
SPL v2
SPL
SPL Set ID 521fe01e-7f2e-4d79-9126-e4880cdf4e71
Route
ORAL
Published
Effective Date 2023-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.43 mg)
Inactive Ingredients
Sorbitol Water Xylitol Hydrated Silica Glycerin Cocamidopropyl Betaine Titanium Dioxide Carboxymethylcellulose Sodium Phosphate, Monobasic Sucralose Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-07-10

Description

Sodium fluoride - 0.243%


Medication Information

Description

Sodium fluoride - 0.243%

Uses:
  • Aids in the prevention of dental decay
Section 50565-1

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

Section 55105-1

Anticavity toothpaste

Warnings:
  • 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 as directed by a dentist or doctor.
  • Instruct children 6 years of age in good brushing and rinsing habits (to minimize swallowing), and and only use a pea size amount.
  • Supervise children as necessary until capable of using without supervision.
  • Chlidren under 2 years of age: Conmsult a dentist or doctor.
Active Ingredient:

Sodium fluoride - 0.243%

Inactive Ingredients:

Sorbitol, Purified Water, Hydrated Silica, Xylitol, Glycerin, Cocamidopropyl Betaine, Flavor, Titanium Dioxide, Carboxymethylcellulose, Sodium Phosphate, Sucralose, Citric Acid

Principal Panel 4.2 Oz Tube

Tanner Tasty Paste                     NDC 11527-180-58

0.243% Sodium Fluoride Toothpaste

Vanilla Bling 

NET WT. 4.2 oz (119g)


Structured Label Content

Uses:
  • Aids in the prevention of dental decay
Section 50565-1 (50565-1)

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

Section 55105-1 (55105-1)

Anticavity toothpaste

Warnings:
  • 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 as directed by a dentist or doctor.
  • Instruct children 6 years of age in good brushing and rinsing habits (to minimize swallowing), and and only use a pea size amount.
  • Supervise children as necessary until capable of using without supervision.
  • Chlidren under 2 years of age: Conmsult a dentist or doctor.
Active Ingredient:

Sodium fluoride - 0.243%

Inactive Ingredients: (Inactive ingredients:)

Sorbitol, Purified Water, Hydrated Silica, Xylitol, Glycerin, Cocamidopropyl Betaine, Flavor, Titanium Dioxide, Carboxymethylcellulose, Sodium Phosphate, Sucralose, Citric Acid

Principal Panel 4.2 Oz Tube (Principal Panel 4.2 OZ Tube)

Tanner Tasty Paste                     NDC 11527-180-58

0.243% Sodium Fluoride Toothpaste

Vanilla Bling 

NET WT. 4.2 oz (119g)


Advanced Ingredient Data


Raw Label Data

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