Enamelon Paste
1626375a-f78b-4192-b7f3-ca932acab7fb
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:08:10.791322 · Updated: 2026-03-14T23:12:20.443473