Enamelon Paste

Enamelon Paste
SPL v7
SPL
SPL Set ID 1626375a-f78b-4192-b7f3-ca932acab7fb
Route
DENTAL
Published
Effective Date 2022-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.00454 g)
Inactive Ingredients
Glycerin Polyethylene Glycol, Unspecified Silicon Dioxide Calcium/sodium Maleate Methyl Vinyl Ether Copolymer (1000000 Mw, 1900 Mpa.s At 11%) Cocamidopropyl Betaine Calcium Sulfate Poloxamer 407 Dimethicone Lauroyl Sarcosine Titanium Dioxide Acesulfame Potassium Sodium Phosphate, Monobasic Sucralose

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-01-01

Description

Stannous fluoride 0.45% (0.16% w/v fluoride ion)

Purpose

Anticavity/Sensitivity Relief/Antigingivitis


Medication Information

Warnings and Precautions

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if gingivitis, bleeding, or redness persists for more than 2 weeks, see your dentist. See your dentist immediately if you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Stop use and ask a dentist if the problem persists or worsens. Do not use this product for sensitivity relief longer than 4 weeks unless recommended by a dentist or doctor.

Purpose

Anticavity/Sensitivity Relief/Antigingivitis

Description

Stannous fluoride 0.45% (0.16% w/v fluoride ion)

Uses
  • Aids in the prevention of cavities
  • Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • Helps prevent gingivitis
  • Helps interfere with the harmful effects of plaque associated with gingivitis
Warnings

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

Directions

Adults and children 2 years of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in 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 doctor.

Distributed By

Premier ® Dental Products Company, Plymouth Meeting, PA 19462

www.premusa.com Part # 9007280 www.enamelon.com

United States Patent Numbers : US 5,993,784, US 5,711,936, US 5,651,959 and other patents pending. Made in U.S.A.

Ultramulsion ® is a registered trademark of WhiteHill Oral Technologies, Inc.

Active Ingredient

Stannous fluoride 0.45% (0.16% w/v fluoride ion)

Other Information
  • Products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • Do not use if foil seal on tube is broken or missing
  • Keep tightly closed when not in use
  • Store at controlled room temperature
Inactive Ingredients

Glycerin, polyethylene glycol, silica, calcium/sodium maleate methyl vinyl ether copolymer, cocamidopropyl betaine, calcium sulfate, poloxamer 407, dimethicone, lauroyl-sarcosine, titanium dioxide, flavor, acesulfame k, monosodium phosphate, sucralose

Questions Or Comments?

Call toll-free 1-888-670-6100

Monday-Thursday 8am-5pm EST, Friday 8am-4pm EST

Principal Display Panel

STRENGTHEN YOUR SMILE!

ACP TM Enamel Therapy

Premier ®

Enamelon ®

Mint Breeze

Fluoride Toothpaste NET WT 4.3 OZ (122 g)

For Anticavity, Antigingivitis & Sensitive Teeth

HYDRAMULSION ®

NDC 48783-520-43


Structured Label Content

Uses
  • Aids in the prevention of cavities
  • Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • Helps prevent gingivitis
  • Helps interfere with the harmful effects of plaque associated with gingivitis
Warnings and Precautions (34071-1)

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if gingivitis, bleeding, or redness persists for more than 2 weeks, see your dentist. See your dentist immediately if you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Stop use and ask a dentist if the problem persists or worsens. Do not use this product for sensitivity relief longer than 4 weeks unless recommended by a dentist or doctor.

Purpose

Anticavity/Sensitivity Relief/Antigingivitis

Warnings

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

Directions

Adults and children 2 years of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in 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 doctor.

Distributed By

Premier ® Dental Products Company, Plymouth Meeting, PA 19462

www.premusa.com Part # 9007280 www.enamelon.com

United States Patent Numbers : US 5,993,784, US 5,711,936, US 5,651,959 and other patents pending. Made in U.S.A.

Ultramulsion ® is a registered trademark of WhiteHill Oral Technologies, Inc.

Active Ingredient (Active ingredient)

Stannous fluoride 0.45% (0.16% w/v fluoride ion)

Other Information (Other information)
  • Products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • Do not use if foil seal on tube is broken or missing
  • Keep tightly closed when not in use
  • Store at controlled room temperature
Inactive Ingredients (Inactive ingredients)

Glycerin, polyethylene glycol, silica, calcium/sodium maleate methyl vinyl ether copolymer, cocamidopropyl betaine, calcium sulfate, poloxamer 407, dimethicone, lauroyl-sarcosine, titanium dioxide, flavor, acesulfame k, monosodium phosphate, sucralose

Questions Or Comments? (Questions or comments?)

Call toll-free 1-888-670-6100

Monday-Thursday 8am-5pm EST, Friday 8am-4pm EST

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

STRENGTHEN YOUR SMILE!

ACP TM Enamel Therapy

Premier ®

Enamelon ®

Mint Breeze

Fluoride Toothpaste NET WT 4.3 OZ (122 g)

For Anticavity, Antigingivitis & Sensitive Teeth

HYDRAMULSION ®

NDC 48783-520-43


Advanced Ingredient Data


Raw Label Data

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