Enamelon Gel

Enamelon Gel
SPL v8
SPL
SPL Set ID 04c3f178-7905-404d-9ac2-67c453287ddf
Route
DENTAL
Published
Effective Date 2018-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.004 g)
Inactive Ingredients
Acesulfame Potassium Calcium Sulfate Calcium/sodium Maleate Methyl Vinyl Ether Copolymer (1000000 Mw, 1900 Mpa.s At 11%) Cocamidopropyl Betaine Dimethicone Glycerin Lauroyl Sarcosine Sodium Phosphate, Monobasic Poloxamer 407 Polyethylene Glycol, Unspecified Silicon Dioxide Sucralose

Identifiers & Packaging

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

Description

Stannous fluoride 0.40% (0.15% 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 0.40% (0.15% 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
Section 42229-5

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.

Clinically Proven Active Ingredient for Anticavity, Antigingivitis and Sensitive Teeth

  • Relieves the discomfort of dry mouth tissues
  • Non-irritating to patients with dry mouth
  • Optimized with calcium and phosphate ions
  • No Sodium Lauryl Sulfate (SLS), No Gluten, No Dyes

​Distributed by:

Premier ® Dental Products Company, Plymouth Meeting, PA 19462

www.premusa.com Part # 9007285 www.enamelon.com

NDC 48783-500-40 021665 Rev4 SP

Warnings

Keep out of the reach of children.

Directions

Adults and children 6 years of age or older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not rinse, eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor.

Active Ingredient

Stannous fluoride 0.40% (0.15% w/v fluoride ion)

Other Information

This is an anticavity/fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using. 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 is broken or missing
  • Keep tightly closed when not in use
  • Store at controlled room temperature
Inactive Ingredients

Acesulfame K, calcium/sodium maleate methyl vinyl ether copolymer, calcium sulfate, cocamidopropyl betaine, dimethicone, flavors, glycerin, lauroyl-sarcosine, monosodium phosphate, poloxamer 407, polyethylene glycol, silica, 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 ®

Preventive Treatment Gel

NET WT 4.0 OZ (113 g)

SENSITIVITY & DRY MOUTH

Clean Mint

HYDRAMULSION ®


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.

Section 42229-5 (42229-5)

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.

Clinically Proven Active Ingredient for Anticavity, Antigingivitis and Sensitive Teeth

  • Relieves the discomfort of dry mouth tissues
  • Non-irritating to patients with dry mouth
  • Optimized with calcium and phosphate ions
  • No Sodium Lauryl Sulfate (SLS), No Gluten, No Dyes

​Distributed by:

Premier ® Dental Products Company, Plymouth Meeting, PA 19462

www.premusa.com Part # 9007285 www.enamelon.com

NDC 48783-500-40 021665 Rev4 SP

Purpose

Anticavity/Sensitivity Relief/Antigingivitis

Warnings

Keep out of the reach of children.

Directions

Adults and children 6 years of age or older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not rinse, eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor.

Active Ingredient (Active ingredient)

Stannous fluoride 0.40% (0.15% w/v fluoride ion)

Other Information (Other information)

This is an anticavity/fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using. 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 is broken or missing
  • Keep tightly closed when not in use
  • Store at controlled room temperature
Inactive Ingredients (Inactive ingredients)

Acesulfame K, calcium/sodium maleate methyl vinyl ether copolymer, calcium sulfate, cocamidopropyl betaine, dimethicone, flavors, glycerin, lauroyl-sarcosine, monosodium phosphate, poloxamer 407, polyethylene glycol, silica, 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 ®

Preventive Treatment Gel

NET WT 4.0 OZ (113 g)

SENSITIVITY & DRY MOUTH

Clean Mint

HYDRAMULSION ®


Advanced Ingredient Data


Raw Label Data

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