Enamelon Gel
04c3f178-7905-404d-9ac2-67c453287ddf
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:08:10.768449 · Updated: 2026-03-14T23:12:20.443473