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SPL v1
SPL
SPL Set ID 5c47a7d5-da34-4658-8006-b36f6477cb9b
Route
dental
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.1 mg)
Inactive Ingredients
water sorbitol hydrated silica glycerin xylitol xanthan gum sodium cocoyl glutamate cocamidopropyl betaine benzyl alcohol rebaudioside a

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2026-01-01
Purpose

Anticavity

Description

Drug Facts

Medication Information

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 (to minimize swallowing)
children under 2 years ask a dentist or physician
Inactive Ingredients

water, sorbitol, hydrated silica, glycerin, xylitol, flavor, xanthan gum, sodium cocoyl glutamate, cocamidopropyl betaine, benzyl alcohol, rebaudioside a.

Description

Drug Facts

Questions?

855-HI-HELLO(1-855-444-3556)

Use

helps protect against cavities

Section 42229-5

Drug Facts

Section 50565-1

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.

Active Ingredient

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

Principal Display Panel 119 G Tube Carton

choose

friendly®

hello®

penguin chill

fluoride toothpaste

cherry mint

natural flavor

NET WT 4.2 OZ (119 g)

Structured Label Content

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 (to minimize swallowing)
children under 2 years ask a dentist or physician
Inactive Ingredients (Inactive ingredients)

water, sorbitol, hydrated silica, glycerin, xylitol, flavor, xanthan gum, sodium cocoyl glutamate, cocamidopropyl betaine, benzyl alcohol, rebaudioside a.

Questions?

855-HI-HELLO(1-855-444-3556)

Use

helps protect against cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Active Ingredient (Active ingredient)

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

Principal Display Panel 119 G Tube Carton (PRINCIPAL DISPLAY PANEL - 119 g Tube Carton)

choose

friendly®

hello®

penguin chill

fluoride toothpaste

cherry mint

natural flavor

NET WT 4.2 OZ (119 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:00.538163 · Updated: 2026-03-14T23:12:08.624404