Sensitive Fluoride Tooth Polish Content Of Label

Sensitive Fluoride Tooth Polish Content Of Label
SPL v1
SPL
SPL Set ID 08c1c9b1-ac5d-4e77-8bc3-778cb5cf3446
Route
TOPICAL
Published
Effective Date 2011-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.26244 g) Potassium Cation (5.4 g)
Inactive Ingredients
Acesulfame Potassium Aloe Vera Leaf Alpha-tocopherol Acetate Ascorbyl Palmitate Carrageenan Glycerin Green Tea Leaf Hydrated Silica Myrrh Oil Papain Poloxamer 407 Potassium Pyrophosphate Sodium Benzoate Sodium Lauryl Sulfate Sodium Pyrophosphate Sorbitol Tea Tree Oil Titanium Dioxide Water Xanthan Gum Xylitol Zinc Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-01-03

Description

Active ingredients Potassium nitrate (5.0% w/w) Sodium fluoride (0.243% w/w)


Medication Information

Warnings and Precautions

Warnings

When using this product do not use longer than four weeks unless recommended by a dentist

Indications and Usage

Uses

  • when used regularly, builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
  • aids in the prevention of cavities

Dosage and Administration

Directions

  • adults and children 12 years of age and older: Apply at least a 1-inch strip of product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
  • children under 12 years of age: consult a dentist or physician

Description

Active ingredients Potassium nitrate (5.0% w/w) Sodium fluoride (0.243% w/w)

Section 42232-9

Other information

This product contains papain, which may cause allergic reactions

Section 50565-1

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

Section 50566-9

Stop use and ask a dentist if problem lasts or gets worse. Sensitive teeth may indicate a serious problem that may need prompt care.

Section 51727-6

Inactive ingredients aloe barbadensis juice powder, ascorbyl palmitate, camellia sinensis leaf extract, chondurs crispus (carrageenan), commiphora myrrha oil, flavor, glycerin, hydrated sisica, melaleuca alternifolia (tea tree) leaf oil, papain, poloxamer 407, potassium acesulfame, sodium alkyl sulfate, sodium benzoate, sorbitol, tetrapotassium pyrophosphate, tetrasodium pyrphosphate, titanium dioxide, tocopheryl acetate, water, xanthan gum, xylitol, zinc citrate

Section 51945-4
Section 55105-1

Purpose

Antisensitivity

Anticavity

Section 55106-9

Active ingredients

Potassium nitrate (5.0% w/w)

Sodium fluoride (0.243% w/w)


Structured Label Content

Indications and Usage (34067-9)

Uses

  • when used regularly, builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
  • aids in the prevention of cavities

Dosage and Administration (34068-7)

Directions

  • adults and children 12 years of age and older: Apply at least a 1-inch strip of product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
  • children under 12 years of age: consult a dentist or physician

Warnings and Precautions (34071-1)

Warnings

When using this product do not use longer than four weeks unless recommended by a dentist

Section 42232-9 (42232-9)

Other information

This product contains papain, which may cause allergic reactions

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a dentist if problem lasts or gets worse. Sensitive teeth may indicate a serious problem that may need prompt care.

Section 51727-6 (51727-6)

Inactive ingredients aloe barbadensis juice powder, ascorbyl palmitate, camellia sinensis leaf extract, chondurs crispus (carrageenan), commiphora myrrha oil, flavor, glycerin, hydrated sisica, melaleuca alternifolia (tea tree) leaf oil, papain, poloxamer 407, potassium acesulfame, sodium alkyl sulfate, sodium benzoate, sorbitol, tetrapotassium pyrophosphate, tetrasodium pyrphosphate, titanium dioxide, tocopheryl acetate, water, xanthan gum, xylitol, zinc citrate

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

Purpose

Antisensitivity

Anticavity

Section 55106-9 (55106-9)

Active ingredients

Potassium nitrate (5.0% w/w)

Sodium fluoride (0.243% w/w)


Advanced Ingredient Data


Raw Label Data

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