native whitening with fluoride

native whitening with fluoride
SPL v6
SPL
SPL Set ID a5248d35-f488-3457-e053-2995a90a411e
Route
dental
Published
Effective Date 2020-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.4 mg)
Inactive Ingredients
titanium dioxide carrageenan xanthan gum water hydrated silica glycerin stevia rebaudiana whole sodium cocoyl glutamate cocamidopropyl betaine xylitol peppermint oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2020-01-01

Purpose

Anticavity toothpaste

Description

Drug Facts


Medication Information

Purpose

Anticavity toothpaste

Directions
  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6
  • supervise children’s brushing until good habits are established
  • children under 2 yrs.: ask a dentist
Inactive Ingredients

glycerin, water, hydrated silica, xylitol, flavor, mentha piperita (peppermint) oil, sodium cocoyl glutamate, xanthan gum, carrageenan, cocamidopropyl betaine, stevia rebaudiana extract, titanium dioxide

Description

Drug Facts

Questions?

1-888-964-1211

Use

helps protect against cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children under 6 yrs 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 0.243% (0.14% w/v fluoride ion)

Principal Display Panel 116 G Tube in Carton

WITH FLUORIDE

WHITENS TEETH

FRESHENS BREATH

FIGHTS CAVITIES

NATIVE

FLUORIDE ANTICAVITY TOOTHPASTE

WHITENING

WILD MINT & PEPPERMINT OIL

NET WT 4.1 OZ (116 g)


Structured Label Content

Purpose

Anticavity toothpaste

Directions
  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6
  • supervise children’s brushing until good habits are established
  • children under 2 yrs.: ask a dentist
Inactive Ingredients (Inactive ingredients)

glycerin, water, hydrated silica, xylitol, flavor, mentha piperita (peppermint) oil, sodium cocoyl glutamate, xanthan gum, carrageenan, cocamidopropyl betaine, stevia rebaudiana extract, titanium dioxide

Questions?

1-888-964-1211

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 yrs 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 0.243% (0.14% w/v fluoride ion)

Principal Display Panel 116 G Tube in Carton (PRINCIPAL DISPLAY PANEL - 116 g tube in carton)

WITH FLUORIDE

WHITENS TEETH

FRESHENS BREATH

FIGHTS CAVITIES

NATIVE

FLUORIDE ANTICAVITY TOOTHPASTE

WHITENING

WILD MINT & PEPPERMINT OIL

NET WT 4.1 OZ (116 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)