Dubai Chocolate Flavor Toothpaste

Dubai Chocolate Flavor Toothpaste
SPL v1
SPL
SPL Set ID d1615a53-ecfc-49d1-b836-f7643b9d2660
Route
DENTAL
Published
Effective Date 2025-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.4 mg)
Inactive Ingredients
Glycerin Water Hydrated Silica Tribasic Calcium Phosphate Menaquinone 7 Cholecalciferol Xylitol Inulin Sodium Gluconate Dimethyl Sulfone Xanthan Gum Cocoa Quillaja Saponaria Whole Benzoic Acid Sodium Ascorbate Stevia Leaf Cranberry Seed Oil Sodium Methyl Cocoyl Taurate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-17

Description

DRUG FACTS ACTIVE INGREDIENT Sodium Fluoride 0.24% (0.15% w/v fluoride ion)


Medication Information

Warnings and Precautions

WARNINGS

Indications and Usage

USE

Aids in the prevention of cavities

Dosage and Administration

DIRECTIONS

  • Children under 3 yrs: use no more than a tiny grain-of-rice smear.
  • Children between 3 and 6: use only a pea sized amount.

  • Place product on SuperMouth® toothbrush and brush teeth thoroughly at least

    twice a day for 2 minutes or use as directed by a Dentist or Physician. Supervise

    child’s brushing and rinsing to minimize swallowing.

Description

DRUG FACTS ACTIVE INGREDIENT Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Section 50565-1

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

Section 51727-6

INACTIVE INGREDIENTS   Glycerin, Water, Hydrated Silica, *Hydroxamin® (Nano-

Hydroxyapatite, Menaquinone-7 (Vitamin K2), Cholecalciferol (Vitamin D3)), Xylitol,

Inulin, Sodium Gluconate, Natural Flavors**, Methylsulfonylmethane, Xanthan Gum,

Cacao Powder, Quillaja Saponaria Extract, Natural Benzoic Acid, Sodium Ascorbate

(Vitamin C), Stevia Leaf Extract, Cranberry Seed Oil, Sodium Methyl Cocoyl Taurate

Section 55105-1

PURPOSE

Anticavity Toothpaste

Section 55106-9

DRUG FACTS

ACTIVE INGREDIENT

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Section 60561-8

If more than used for brushing is accidentally swallowed, get medical help or

contact a Poison Control Center right away.

ALWAYS FOLLOW LABEL

Product Labeling: dubai Chocolate Flavor Toothpaste

..........................................................................

Supermouth

dubai chocolate

    flavor

fluoride toothpaste

safe • effective • fun

3.4 oz (96 g)

SuperMouth®

9737 Aero Drive,

San Diego, CA 92123

(844) MOUTHCARE

Carton Label

Tube Label

res


Structured Label Content

Indications and Usage (34067-9)

USE

Aids in the prevention of cavities

Dosage and Administration (34068-7)

DIRECTIONS

  • Children under 3 yrs: use no more than a tiny grain-of-rice smear.
  • Children between 3 and 6: use only a pea sized amount.

  • Place product on SuperMouth® toothbrush and brush teeth thoroughly at least

    twice a day for 2 minutes or use as directed by a Dentist or Physician. Supervise

    child’s brushing and rinsing to minimize swallowing.

Warnings and Precautions (34071-1)

WARNINGS

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS   Glycerin, Water, Hydrated Silica, *Hydroxamin® (Nano-

Hydroxyapatite, Menaquinone-7 (Vitamin K2), Cholecalciferol (Vitamin D3)), Xylitol,

Inulin, Sodium Gluconate, Natural Flavors**, Methylsulfonylmethane, Xanthan Gum,

Cacao Powder, Quillaja Saponaria Extract, Natural Benzoic Acid, Sodium Ascorbate

(Vitamin C), Stevia Leaf Extract, Cranberry Seed Oil, Sodium Methyl Cocoyl Taurate

Section 55105-1 (55105-1)

PURPOSE

Anticavity Toothpaste

Section 55106-9 (55106-9)

DRUG FACTS

ACTIVE INGREDIENT

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Section 60561-8 (60561-8)

If more than used for brushing is accidentally swallowed, get medical help or

contact a Poison Control Center right away.

ALWAYS FOLLOW LABEL

Product Labeling: dubai Chocolate Flavor Toothpaste (Product Labeling: Dubai Chocolate Flavor Toothpaste)

..........................................................................

Supermouth

dubai chocolate

    flavor

fluoride toothpaste

safe • effective • fun

3.4 oz (96 g)

SuperMouth®

9737 Aero Drive,

San Diego, CA 92123

(844) MOUTHCARE

Carton Label

Tube Label

res


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)