Kids Prime Pediatric Dental Group Anticavity Toothpaste For Kids

Kids Prime Pediatric Dental Group Anticavity Toothpaste For Kids
SPL v2
SPL
SPL Set ID 93259174-447d-4f7a-8e55-990eb8da5151
Route
DENTAL
Published
Effective Date 2025-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.5 mg)
Inactive Ingredients
Sorbitol Water Hydrated Silica Polyethylene Glycol 14000 Glycerin Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Xanthan Gum Sodium Benzoate Carrageenan Saccharin Sodium Sodium Pyrophosphate Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-31
Description

Sodium fluoride 0.25%

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Sodium fluoride 0.25%

Use

helps protect against cavities

Warnings

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.
 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 physician

Drug Facts

Active Ingredient

Sodium fluoride 0.25%

Other Information

Store in a cool place, below 86°F, away from heat

Do not use if quality seal is broken or missing

Do not use after the expiration date

Inactive Ingredients

Sorbitol, Aqua, Hydrated Silica, PEG-300, Glycerin, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Xanthan Gum, Sodium Benzoate, Carrageenan, Saccharin Sodium, Sodium Pyrophosphate, FD&C Blue No.1.

Package Labeling: 25g

Package Labeling: 50g

Keep Out of Reach of Children Under 6 Years of Age.

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

Structured Label Content

Use

helps protect against cavities

Purpose

Anticavity

Warnings

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.
 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 physician

Drug Facts

Active Ingredient

Sodium fluoride 0.25%

Other Information (Other information)

Store in a cool place, below 86°F, away from heat

Do not use if quality seal is broken or missing

Do not use after the expiration date

Inactive Ingredients (Inactive ingredients)

Sorbitol, Aqua, Hydrated Silica, PEG-300, Glycerin, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Xanthan Gum, Sodium Benzoate, Carrageenan, Saccharin Sodium, Sodium Pyrophosphate, FD&C Blue No.1.

Package Labeling: 25g

Package Labeling: 50g

Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:27.230160 · Updated: 2026-03-14T23:12:39.597935