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SPL v1
SPL
SPL Set ID 38a0276e-910c-527d-1736-65928b9d4ca4
Route
dental
Published
Effective Date 2023-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.5 mg)
Inactive Ingredients
water hydrated silica sorbitol glycerin xylitol sodium tripolyphosphate anhydrous sodium pyrophosphate sodium ascorbyl phosphate carboxymethylcellulose sodium, unspecified sodium cocoyl glutamate cocamidopropyl betaine xanthan gum rebaudioside a annatto

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
otc monograph drug active Since 2024-01-01
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
chldren 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, hydrated silica, sorbitol, glycerin, xylitol, pentasodium triphosphate, tetrapotassium pyrophosphate, sodium ascorbyl phosphate (vitamin c), flavor, cellulose gum, sodium cocoyl glutamate, cocamidopropyl betaine, xanthan gum, rebaudioside a, annatto

natural annatto pigment provides orange color
.

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 113 G Tube Carton

hello®

vitamin c

whitening

2 shades whiter*

C

the

sparkle

natural peppermint

anticavity fluoride toothpaste

NET WT 4.0 OZ (113 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
chldren 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, hydrated silica, sorbitol, glycerin, xylitol, pentasodium triphosphate, tetrapotassium pyrophosphate, sodium ascorbyl phosphate (vitamin c), flavor, cellulose gum, sodium cocoyl glutamate, cocamidopropyl betaine, xanthan gum, rebaudioside a, annatto

natural annatto pigment provides orange color
.

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 113 G Tube Carton (PRINCIPAL DISPLAY PANEL - 113 g Tube Carton)

hello®

vitamin c

whitening

2 shades whiter*

C

the

sparkle

natural peppermint

anticavity fluoride toothpaste

NET WT 4.0 OZ (113 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:37.378873 · Updated: 2026-03-14T23:02:18.218337