Eurofresh Whitening Toothpaste

Eurofresh Whitening Toothpaste
SPL v2
SPL
SPL Set ID b56b2b55-e3a4-785a-e053-2a95a90a7abf
Route
TOPICAL
Published
Effective Date 2020-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.08 mg)
Inactive Ingredients
Calcium Carbonate Sorbitol Water Hydrated Silica Lauryl Glucoside Xanthan Gum Titanium Dioxide Sodium Benzoate Saccharin Sodium Tea Tree Oil Asian Ginseng Aloe Vera Leaf Salvadora Persica Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-01

Description

Sodium Fluoride - 0.24%

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride - 0.24%

Use

Helps protect against cavities

Helps whiten teeth

Warnings

Direction
  • Supervise children as necessary until capable of using without supervision.
  • Do not swallow.
  • Rinse away toothpaste residue thoroughly after brushing.
  • Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician.
  • Children under 6 years: instruct in good brushing and rinsing habits (to minimize swallowing).
  • Children under 2 years: ask a dentist or physician.
Drug Facts

Do Not Use

if irritation occurs and persists.

Package Labeling:

Active Ingredients

Sodium Fluoride - 0.24%

Inactive Ingredients

Calcium Carbonate, Sorbitol, Water/Aqua, Hydrated Silica, Lauryl Glucoside, Xanthan Gum, Flavour/Aroma, Titanium Dioxide, Sodium Benzoate, Sodium Saccharin, Tea Tree Oil/Melaleuca alternifolia Leaf Oil, Panax Ginseng Root Extract, aloe Juice Barbadensis Leaf juice, Salvadora Persica Bark/Root Extract.

Questions Or Comments?

[email protected] 1786 236 7338

Monday - Friday (9 a.m-6 p.m. EST)

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.


Structured Label Content

Use (USE)

Helps protect against cavities

Helps whiten teeth

Purpose (PURPOSE)

Anticavity

Warnings (WARNINGS)

Direction (DIRECTION)
  • Supervise children as necessary until capable of using without supervision.
  • Do not swallow.
  • Rinse away toothpaste residue thoroughly after brushing.
  • Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician.
  • Children under 6 years: instruct in good brushing and rinsing habits (to minimize swallowing).
  • Children under 2 years: ask a dentist or physician.
Drug Facts (DRUG FACTS)

Do Not Use (Do not use)

if irritation occurs and persists.

Package Labeling:

Active Ingredients (ACTIVE INGREDIENTS)

Sodium Fluoride - 0.24%

Inactive Ingredients (INACTIVE INGREDIENTS)

Calcium Carbonate, Sorbitol, Water/Aqua, Hydrated Silica, Lauryl Glucoside, Xanthan Gum, Flavour/Aroma, Titanium Dioxide, Sodium Benzoate, Sodium Saccharin, Tea Tree Oil/Melaleuca alternifolia Leaf Oil, Panax Ginseng Root Extract, aloe Juice Barbadensis Leaf juice, Salvadora Persica Bark/Root Extract.

Questions Or Comments? (Questions or Comments?)

[email protected] 1786 236 7338

Monday - Friday (9 a.m-6 p.m. EST)

Keep Out of Reach of Children (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.


Advanced Ingredient Data


Raw Label Data

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