Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 7a295974-c400-4442-9149-138a805ffb20
Route
DENTAL
Published
Effective Date 2023-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.43 mg)
Inactive Ingredients
Sorbitol Silicon Dioxide Water Glycerin Polyethylene Glycol 1500 Sodium Lauryl Sulfate Titanium Dioxide Carboxymethylcellulose Sodium Carrageenan Xanthan Gum Butyl Ester Of Methyl Vinyl Ether/maleic Anhydride Copolymer (125000 Mw) Sodium Phosphate, Tribasic, Dodecahydrate Saccharin Sodium Sodium Pyrophosphate Sodium Benzoate Methylparaben Propylparaben Benzyl Alcohol Triclosan Propylene Glycol Sodium Hydroxide Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-24

Description

Sodium fluoride - 0.243% (0.15% w/v Fluoride ion)

Purpose

Anti-cavity


Medication Information

Purpose

Anti-cavity

Description

Sodium fluoride - 0.243% (0.15% w/v Fluoride ion)

Use:

Helps protect against cavities

Section 50565-1

KEEP OUT OF THE REACH OF CHILDREN UNDER 6 YEARS OF AGE. If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.

Purpose:

Anti-cavity

Directions:

Adults and Children 6-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 a physician.

Children 2 to 6 years

Use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years

Ask a dentist or a physician

Active Ingredient:

Sodium fluoride - 0.243% (0.15% w/v Fluoride ion)

Other Ingredients:

Sorbitol, Silica, Treated Water, Poly Ethylene Glycol 1500, Sodium Lauryl Sulfate, Flavor, Titanium Dioxide, Cellulose gum and/or Carrageenan, Trisodium Orthophosphate, Sodium Saccharin, Tetra Sodium Pyrophosphate, Glycerin, Color: FD&C Blue #1

Package date and batch number on crimp.

Principal Display Panel – 24 G Box Label

Quantum Fresh

FLUORIDE TOOTHPASTE

Quantum

a safco company

800-328-8213

www.QuantumLabs.com

Fluoride Toothpaste

Reorder # 826-0001

Net Wt. 0.85 oz (24 g)

Expiration Date:

2 years from date

packed.

NDC 67239-0226-0

Made in India


Structured Label Content

Use:

Helps protect against cavities

Section 50565-1 (50565-1)

KEEP OUT OF THE REACH OF CHILDREN UNDER 6 YEARS OF AGE. If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.

Purpose:

Anti-cavity

Directions:

Adults and Children 6-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 a physician.

Children 2 to 6 years

Use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years

Ask a dentist or a physician

Active Ingredient: (Active ingredient:)

Sodium fluoride - 0.243% (0.15% w/v Fluoride ion)

Other Ingredients: (Other ingredients:)

Sorbitol, Silica, Treated Water, Poly Ethylene Glycol 1500, Sodium Lauryl Sulfate, Flavor, Titanium Dioxide, Cellulose gum and/or Carrageenan, Trisodium Orthophosphate, Sodium Saccharin, Tetra Sodium Pyrophosphate, Glycerin, Color: FD&C Blue #1

Package date and batch number on crimp.

Principal Display Panel – 24 G Box Label (Principal Display Panel – 24 g Box Label)

Quantum Fresh

FLUORIDE TOOTHPASTE

Quantum

a safco company

800-328-8213

www.QuantumLabs.com

Fluoride Toothpaste

Reorder # 826-0001

Net Wt. 0.85 oz (24 g)

Expiration Date:

2 years from date

packed.

NDC 67239-0226-0

Made in India


Advanced Ingredient Data


Raw Label Data

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