Super Mint Flouride Toothpaste

Super Mint Flouride Toothpaste
SPL v1
SPL
SPL Set ID be0915f3-36c4-4200-9d15-704cfbd632b4
Route
DENTAL
Published
Effective Date 2025-07-05
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 Quillaja Saponaria Whole Sodium Methyl Cocoyl Taurate Benzoic Acid Sodium Ascorbate Stevia Leaf Cranberry Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-30

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, Natural Flavors, Sodium Gluconate, Methylsulfonylmethane, Xanthan

Gum, Quillaja Saponaria Extract, Sodium Methyl Cocoyl Taurate, Natural Benzoic

Acid, Sodium Ascorbate (Vitamin C), Stevia Leaf Extract, Cranberry Seed Oil.

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: Super Mint Flouride Toothpaste

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

Supermouth

super mint

fluoride toothpaste

safe • effective • fun

3.4 oz (96 g)

SuperMouth®

9737 Aero Drive,

San Diego, CA 92123

(844) MOUTHCARE

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, Natural Flavors, Sodium Gluconate, Methylsulfonylmethane, Xanthan

Gum, Quillaja Saponaria Extract, Sodium Methyl Cocoyl Taurate, Natural Benzoic

Acid, Sodium Ascorbate (Vitamin C), Stevia Leaf Extract, Cranberry Seed Oil.

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: Super Mint Flouride Toothpaste

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

Supermouth

super mint

fluoride toothpaste

safe • effective • fun

3.4 oz (96 g)

SuperMouth®

9737 Aero Drive,

San Diego, CA 92123

(844) MOUTHCARE

res


Advanced Ingredient Data


Raw Label Data

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