Whitening Formula

Whitening Formula
SPL v1
SPL
SPL Set ID dbd98251-c137-4066-9645-f8b8ca71de16
Route
DENTAL
Published
Effective Date 2011-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.76 mL)
Inactive Ingredients
Water Anhydrous Dibasic Calcium Phosphate Silicon Dioxide Glycerin Sorbitol Papaya Pineapple Spearmint Oil Mentha Arvensis Leaf Oil Usnea Barbata Angelica Root Oil Parsley Seed Oil Fennel Oil Sodium Lauryl Sulfate Propylene Glycol Saccharin Sodium Dihydrate Sodium Benzoate Propylparaben Sodium Methylparaben Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2004-08-01

Description

Drug Facts

Purpose

Fluoride toothpaste


Medication Information

Purpose

Fluoride toothpaste

Description

Drug Facts

Use

Aids in the prevention of dental cavities.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children under 6 years of age.

Section 50567-7

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 doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Supervise children as neccessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.
Ingredients

water, dicalcium phosphate, calcium carbonate, silica, glycerin, sorbitol, algin, carica papaya (papaya) fruit extract, ananas sativus (pineapple) fruit extract, mentha viridis (spearmint) leaf oil, mentha arvensis leaf oil, usnea barbata (lichen) extract, angelica archangelica root oil, carum petroselinum (parsley) seed oil, foeniculum vulgare (fennel) oil, sodium lauryl sulfate, propylene glycol, sodium saccharin, limonene, sodium benzoate, sodium propylparaben, sodium methylparaben <ILN36886>.

Active Ingredient

Sodium monofluorophosphate 0.76%

Principal Display Panel 75ml Carton

WHITENING FORMULA

DENBLAN

ANTICAVITY FLUORIDE TOOTHPASTE

REFRESHING MINT TASTE

e 75mL

POIDS NET WT. 2.6 OZ.


Structured Label Content

Use

Aids in the prevention of dental cavities.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age.

Section 50567-7 (50567-7)

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Fluoride toothpaste

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 doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Supervise children as neccessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.
Ingredients

water, dicalcium phosphate, calcium carbonate, silica, glycerin, sorbitol, algin, carica papaya (papaya) fruit extract, ananas sativus (pineapple) fruit extract, mentha viridis (spearmint) leaf oil, mentha arvensis leaf oil, usnea barbata (lichen) extract, angelica archangelica root oil, carum petroselinum (parsley) seed oil, foeniculum vulgare (fennel) oil, sodium lauryl sulfate, propylene glycol, sodium saccharin, limonene, sodium benzoate, sodium propylparaben, sodium methylparaben <ILN36886>.

Active Ingredient (Active ingredient)

Sodium monofluorophosphate 0.76%

Principal Display Panel 75ml Carton (PRINCIPAL DISPLAY PANEL - 75mL Carton)

WHITENING FORMULA

DENBLAN

ANTICAVITY FLUORIDE TOOTHPASTE

REFRESHING MINT TASTE

e 75mL

POIDS NET WT. 2.6 OZ.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)