Classic Tooth Polish Cool Mint With Fluoride

Classic Tooth Polish Cool Mint With Fluoride
SPL v3
SPL
SPL Set ID 6893405a-a2c4-068e-e053-2a91aa0ae5b1
Route
TOPICAL
Published
Effective Date 2011-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.26244 g)
Inactive Ingredients
Aloe Vera Leaf Ascorbyl Palmitate Green Tea Leaf Myrrh Oil Glycerin Hydrated Silica Tea Tree Oil Papain Poloxamer 407 Acesulfame Potassium Sodium Lauryl Sulfate Sodium Benzoate Sorbitol Potassium Pyrophosphate Sodium Pyrophosphate Titanium Dioxide Alpha-tocopherol Acetate Water Xanthan Gum Xylitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-04-01

Description

Active ingredient Sodium Fluoride (0.243%)


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Use aids in the prevention of dental cavities

Dosage and Administration

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 physician
  • instruct children under 6 years of age on good brushing and rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 2 years of age: consult a dentist or physician

Description

Active ingredient Sodium Fluoride (0.243%)

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. Warning: This product contains propolis, which can cause allergic reactions.

Section 51727-6

Inactive ingredients: aloe barbadensis, ascorbyl palmitate, camellia sinensis leaf extract, commiphora myrrha oil, flavor, glycerin, hydrated silica, melaleuca alternifolia (tea tree) leaf oil, papain, poloxamer 407, potassium acesulfame, propolis extract, sodium alkyl sulfate, sodium benzoate, sorbitol, tetrapotassium pyrophosphate, tetrasodium pyrophosphate, titanium dioxide, tocopheryl acetate, water, xanthan gum, xylitol

Section 51945-4

Section 55105-1

Purpose

Anticavity

Section 55106-9

Active ingredient

Sodium Fluoride (0.243%)


Structured Label Content

Indications and Usage (34067-9)

Use aids in the prevention of dental cavities

Dosage and Administration (34068-7)

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 physician
  • instruct children under 6 years of age on good brushing and rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 2 years of age: consult a dentist or physician

Warnings and Precautions (34071-1)

Warnings

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. Warning: This product contains propolis, which can cause allergic reactions.

Section 51727-6 (51727-6)

Inactive ingredients: aloe barbadensis, ascorbyl palmitate, camellia sinensis leaf extract, commiphora myrrha oil, flavor, glycerin, hydrated silica, melaleuca alternifolia (tea tree) leaf oil, papain, poloxamer 407, potassium acesulfame, propolis extract, sodium alkyl sulfate, sodium benzoate, sorbitol, tetrapotassium pyrophosphate, tetrasodium pyrophosphate, titanium dioxide, tocopheryl acetate, water, xanthan gum, xylitol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Anticavity

Section 55106-9 (55106-9)

Active ingredient

Sodium Fluoride (0.243%)


Advanced Ingredient Data


Raw Label Data

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