Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 69c07c36-b5e0-420b-ab29-7d1091386322
Route
DENTAL
Published
Effective Date 2024-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.10 mg)
Inactive Ingredients
Water Sorbitol Hydrated Silica Glycerin Polyethylene Glycol 400 Cocamidopropyl Betaine Xanthan Gum Saccharin Sodium Sodium Hydroxide D&c Red No. 30

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-06
Description

Sodium fluoride 0.254% (0.15% w/v fluoride ion)

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Sodium fluoride 0.254% (0.15% w/v fluoride ion)

Use
  • •
    aids in the prevention of dental cavities.
Directions
  • •
    adults and children 2 years of age and older:
  •  
    • o
      brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
    • o
      to minimize swallowing for children under 6 years of age, use a pea-sized amount and rinsing until good habits are established.
  • •
    children under 2 years of age: Consult a dentist or doctor.
Active Ingredient

Sodium fluoride 0.254% (0.15% w/v fluoride ion)

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

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, xanthan gum, flavor, sodium saccharin, sodium hydroxide, red 30

Questions Or Comments?

1-866-844-2797

ALWAYS FOLLOW THE LABEL

Principal Display Panel

FLUORIDE ANTICAVITY TOOTHPASTE

new HALEON

Sensodyne PRONAMEL

KIDS

Berry Twist

24hr Cavity Protection*

2x Stronger Enamel Defense**

NET WT 4.0 OZ (113 g)

62000000212335 Front Label

Keep Out of the 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
  • •
    aids in the prevention of dental cavities.
Purpose

Anticavity

Directions
  • •
    adults and children 2 years of age and older:
  •  
    • o
      brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
    • o
      to minimize swallowing for children under 6 years of age, use a pea-sized amount and rinsing until good habits are established.
  • •
    children under 2 years of age: Consult a dentist or doctor.
Active Ingredient (Active ingredient)

Sodium fluoride 0.254% (0.15% w/v fluoride ion)

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

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, xanthan gum, flavor, sodium saccharin, sodium hydroxide, red 30

Questions Or Comments? (Questions or comments?)

1-866-844-2797

ALWAYS FOLLOW THE LABEL

Principal Display Panel

FLUORIDE ANTICAVITY TOOTHPASTE

new HALEON

Sensodyne PRONAMEL

KIDS

Berry Twist

24hr Cavity Protection*

2x Stronger Enamel Defense**

NET WT 4.0 OZ (113 g)

62000000212335 Front Label

Keep Out of the Reach of Children Under 6 Years of Age. (Keep out of the 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: 2026-02-15T12:06:27.678517 · Updated: 2026-03-14T23:09:13.832086