85162-004 Adoptaplatoon

85162-004 Adoptaplatoon
SPL v1
SPL
SPL Set ID c1592b56-cf3d-4a4d-be84-e40eb3f1456e
Route
DENTAL
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 g)
Inactive Ingredients
Saccharin Sodium Sorbitol Methylparaben Sodium Hydrated Silica Sodium Lauryl Sulfate Propylparaben Sodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-20
Description

Sodium Fluoride 0.22%(0.1 w/v Fluoride ion)

Purpose

anticavity

Medication Information

Purpose

anticavity

Description

Sodium Fluoride 0.22%(0.1 w/v Fluoride ion)

Uses

Help protect against dental cavities.

Section 50565-1

Keep out of reach of children.

Section 51945-4

Warnings

Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed,get medical help or contact a Poison Control Center immediately.

Directions

Adult and children six years of age or older:

  • Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a physician. 

Children 2-6:

  • Use only a pea sized amount and supervise children's brushing and rinsing to minimize swallowing.

Children under 2:

  • Ask a dentist or physician
Active Ingredients

Sodium Fluoride 0.22%(0.1 w/v Fluoride ion)

Inactive Ingredient

Sorbitol, Silica,Methyl Paraben Sodium, Propyl Paraben Sodium, Sodium Saccharin, Flavor, Water, SCMC, Sodium Lauryl Sulfate

Structured Label Content

Uses

Help protect against dental cavities.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Purpose

anticavity

Warnings

Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed,get medical help or contact a Poison Control Center immediately.

Directions

Adult and children six years of age or older:

  • Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a physician. 

Children 2-6:

  • Use only a pea sized amount and supervise children's brushing and rinsing to minimize swallowing.

Children under 2:

  • Ask a dentist or physician
Active Ingredients (Active ingredients)

Sodium Fluoride 0.22%(0.1 w/v Fluoride ion)

Inactive Ingredient (INACTIVE INGREDIENT)

Sorbitol, Silica,Methyl Paraben Sodium, Propyl Paraben Sodium, Sodium Saccharin, Flavor, Water, SCMC, Sodium Lauryl Sulfate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:46.835123 · Updated: 2026-03-14T23:08:04.646392