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spl product data elements
Enamelon Preventive Treatment stannous fluoride 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 STANNOUS FLUORIDE FLUORIDE ION Clean Mint
活性成分 / Active ingredient
Active ingredient Stannous fluoride 0.40% (0.15% w/v fluoride ion)
用途 / Purpose
Purpose Anticavity/Sensitivity Relief/Antigingivitis
适应证 / Indications and usage
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
儿童安全 / Keep out of reach of children
Warnings Keep out of the reach of children.
警告 / Warnings
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.
用法用量原文 / Dosage and administration
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.
spl unclassified section
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
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
辅料 / 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
Questions or comments? Call toll-free 1-888-670-6100 Monday-Thursday 8am-5pm EST, Friday 8am-4pm EST
package label 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 ® Enamelon Gel Box
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 8 / 20260113
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.

