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SPL v4
SPL
SPL Set ID bdabf74f-8d1e-0f11-159a-0025bcd0ca3e
Route
DENTAL
Published
Effective Date 2025-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg)
Inactive Ingredients
Glycerin Sorbitol Water Hydrated Silica Erythritol Xylitol Xanthan Gum Sodium Bicarbonate Lauryl Glucoside Potassium Citrate Sodium Pyrophosphate Rebaudioside A

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-01

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

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.

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
Questions?

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

Active Ingredient

Sodium fluoride 0.24% (0.14% w/v fluoride ion)

Inactive Ingredients

glycerin, sorbitol, water, hydrated silica, erythritol, xylitol, xanthan gum, sodium bicarbonate, lauryl glucoside, potassium citrate, tetrasodium pyrophosphate, rebaudioside a, flavor.

Principal Display Panel 119 G Tube Carton

choose

friendly®

hello®

magical mermaid

fluoride toothpaste

kids ages 2+

orange dreamsicle

natural flavor

prevents cavities

polishes + brightens

strengthens enamel

tastes magical

not tested

on mermaids

no artificial sweeteners. no dyes.

no SLS. no brainer.

NET WT 4.2 OZ (119 g)


Structured Label Content

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.

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
Questions?

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

Active Ingredient

Sodium fluoride 0.24% (0.14% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

glycerin, sorbitol, water, hydrated silica, erythritol, xylitol, xanthan gum, sodium bicarbonate, lauryl glucoside, potassium citrate, tetrasodium pyrophosphate, rebaudioside a, flavor.

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

choose

friendly®

hello®

magical mermaid

fluoride toothpaste

kids ages 2+

orange dreamsicle

natural flavor

prevents cavities

polishes + brightens

strengthens enamel

tastes magical

not tested

on mermaids

no artificial sweeteners. no dyes.

no SLS. no brainer.

NET WT 4.2 OZ (119 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)