Orapro Fluoride Anticavity Toothpaste

Orapro Fluoride Anticavity Toothpaste
SPL v4
SPL
SPL Set ID 93b0181c-e29f-42f4-80f5-366463b68f09
Route
ORAL
Published
Effective Date 2025-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.4 mg)
Inactive Ingredients
Glycerin Water Cellulose Gum Calcium Carboxymethyl Cellulose Hydrated Silica Cocamidopropyl Betaine Sodium Gluconate Carbomer 980 Sodium Benzoate Methyl Vinyl Ether And Maleic Acid Copolymer (1750000 Wamw) Poloxamer 407 Xanthan Gum Sodium Hydroxide Benzyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-30

Description

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Use

Helps protect agaisnt cavities

Purpose 

Anticavity

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 physician. Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing habits (to minimize swallowing). Supervise children as nessary until capable of using without supervision. Children under 2 years ask a dentist or physician

Warnings 

If  more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away

Drug Facts 

Active Ingredient

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients:

 Glycerol, Water, Hydrated Silica, Crystalline Cellulose, Cellulose, Flavor, Cocamidopropyl Betaine, Sodium Gluconate, Carbomer, Sodium Benzoate, PVM/MA Copolymer, Poloxamer 407, Xanthan Gum, Sodium Hydroxide, Benzyl Alcohol.

Principal Display Panel 

OraPro Paste    NDC 83610-1060-1

Advanced Biofilm Removal

Fluoride AnitCavity Toothpaste

NET WT 5.2 OZ (147g)


Structured Label Content

Use

Helps protect agaisnt cavities

Purpose 

Anticavity

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 physician. Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing habits (to minimize swallowing). Supervise children as nessary until capable of using without supervision. Children under 2 years ask a dentist or physician

Warnings 

If  more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away

Drug Facts 

Active Ingredient (Active ingredient)

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients: (Inactive ingredients:)

 Glycerol, Water, Hydrated Silica, Crystalline Cellulose, Cellulose, Flavor, Cocamidopropyl Betaine, Sodium Gluconate, Carbomer, Sodium Benzoate, PVM/MA Copolymer, Poloxamer 407, Xanthan Gum, Sodium Hydroxide, Benzyl Alcohol.

Principal Display Panel 

OraPro Paste    NDC 83610-1060-1

Advanced Biofilm Removal

Fluoride AnitCavity Toothpaste

NET WT 5.2 OZ (147g)


Advanced Ingredient Data


Raw Label Data

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