Moon Platinum Advanced Whitening Anticavity Toothpaste

Moon Platinum Advanced Whitening Anticavity Toothpaste
SPL v3
SPL
SPL Set ID ded3a5a6-2883-f3de-e053-2a95a90afb94
Route
TOPICAL
Published
Effective Date 2022-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.24 g)
Inactive Ingredients
Cellulose Gum Propylene Glycol Tea Tree Oil Peppermint Oil Water Carrageenan Magnesium Potassium Aluminosilicate Fluoride Xylitol Titanium Dioxide Menthol Mica Glycerin Hydrated Silica Kaolin Sodium Lauroyl Sarcosinate Myrciaria Dubia Fruit Asian Ginseng Saccharin Sodium Coconut Oil Cranberry Seed Oil Green Tea Leaf Ferric Oxide Red Sea Salt Echinacea Angustifolia Leaf Camellia Sinensis Leaf Oil Gaultheria Procumbens (wintergreen) Leaf Oil Limonene, (+)- Sloe Hydroxyapatite Ethylhexylglycerin Caprylyl Glycol Sodium Oleoyl Glutamate Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-25

Description

Active Ingredient Purpose Sodium Fluoride 0.24% (0.13% w/v fluoride ion)


Medication Information

Warnings and Precautions

Keep out of reach of children under 6 years of age.If more than than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Contains Sodium Fluoride. In case of intake of flouride from other sources consult a dentist or doctor.

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

Indications and Usage

Aids in the prevention of dental cavities.

Dosage and Administration

Topical Paste

Description

Active Ingredient Purpose Sodium Fluoride 0.24% (0.13% w/v fluoride ion)

Section 50565-1

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.

Section 51727-6

Inactive ingredients

Glycerin, Water, Hydrated Silica, Xylitol, Faultheria Procumbens (Wintergreen) Leaf Oil, Hydroxyapatite, Synthetic Fluorophlogopite, Cellulose Gum, Mentha Piperita (Peppermint) Oil, Kaolin, Sodium Lauroyl Sarcosinate, Carrageenan, Flavor, Titanium Dioxide, Sodium Saccharin, Sodium Fluoride, Menthol, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol, Propylene Glycol, Sodium Olivoyl Glutamate, Mica, Limonene, Cocos Nucifera (Coconut) Oil, Prunus Spinosa Fruit Extract, Vaccinium Macrocarpon (Cranberry) Seed Oil, Iron Oxides, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sea Salt, Camellia Sinensis Leaf Extract, Echinacea Angustifolia Leaf Extract, Myciaria Dubia Fruit Extract, Panax Ginseng Root Extract

Section 51945-4

Moon Platinum

Advanced Whitening

Fluoride

Premium Freshening

Anticavity Toothpaste

Platinum Mint

119 g Net Wt. 4.2 OZ

Section 53413-1

1(800) 949-8108

www.moonoralcare.com

Section 55105-1

Anticavity

Section 55106-9

Active Ingredient Purpose

Sodium Fluoride 0.24% (0.13% w/v fluoride ion)

Section 59845-8

Directions

adults and children 2 years and older:

  • brush teeth thoroughly after meals 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 years ask a dentist

Structured Label Content

Indications and Usage (34067-9)

Aids in the prevention of dental cavities.

Dosage and Administration (34068-7)

Topical Paste

Warnings and Precautions (34071-1)

Keep out of reach of children under 6 years of age.If more than than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Contains Sodium Fluoride. In case of intake of flouride from other sources consult a dentist or doctor.

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients

Glycerin, Water, Hydrated Silica, Xylitol, Faultheria Procumbens (Wintergreen) Leaf Oil, Hydroxyapatite, Synthetic Fluorophlogopite, Cellulose Gum, Mentha Piperita (Peppermint) Oil, Kaolin, Sodium Lauroyl Sarcosinate, Carrageenan, Flavor, Titanium Dioxide, Sodium Saccharin, Sodium Fluoride, Menthol, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol, Propylene Glycol, Sodium Olivoyl Glutamate, Mica, Limonene, Cocos Nucifera (Coconut) Oil, Prunus Spinosa Fruit Extract, Vaccinium Macrocarpon (Cranberry) Seed Oil, Iron Oxides, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sea Salt, Camellia Sinensis Leaf Extract, Echinacea Angustifolia Leaf Extract, Myciaria Dubia Fruit Extract, Panax Ginseng Root Extract

Section 51945-4 (51945-4)

Moon Platinum

Advanced Whitening

Fluoride

Premium Freshening

Anticavity Toothpaste

Platinum Mint

119 g Net Wt. 4.2 OZ

Section 53413-1 (53413-1)

1(800) 949-8108

www.moonoralcare.com

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)

Active Ingredient Purpose

Sodium Fluoride 0.24% (0.13% w/v fluoride ion)

Section 59845-8 (59845-8)

Directions

adults and children 2 years and older:

  • brush teeth thoroughly after meals 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 years ask a dentist

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)