说明与适用边界
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spl product data elements
ACT Restoring Anticavity Fluoride Mint Burst Sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL POLOXAMER 407 PROPYLENE GLYCOL SODIUM PHOSPHATE POLYSORBATE 20 SACCHARIN SODIUM SUCRALOSE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS CETYLPYRIDINIUM CHLORIDE EDETATE CALCIUM DISODIUM ANHYDROUS SODIUM BENZOATE POTASSIUM SORBATE FD&C YELLOW NO. 5 FD&C GREEN NO. 3
spl unclassified section
ACT ® Restoring ™ Mint Burst Anticavity Fluoride Rinse Drug Facts
Other information contains FD&C yellow no. 5 (tartrazine) as a color additive do not use if safety seal is broken or missing
活性成分 / Active ingredient
Active i ngredient Sodium fluoride 0.02% (0.009% w/v fluoride ion)
用途 / Purpose
Purpose Anticavity
适应证 / Indications and usage
Use aids in the prevention of dental cavities
警告 / Warnings
W arnings Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
儿童安全 / Keep out of reach of children
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
用法用量原文 / Dosage and administration
Directions a dults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste remove cap pour 10 milliliters into cap (10 mL mark on inside of cap); do not fill above 10 mL mark vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision c hildren under 6 years of age: consult a dentist or doctor
辅料 / Inactive ingredients
Inactive ingredients water, sorbitol, poloxamer 407, propylene glycol, sodium phosphate, polysorbate 20, sodium saccharin, sucralose, disodium phosphate, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, potassium sorbate, flavor, yellow 5, green 3 (309-165)
package label principal display panel
PRINCIPAL DISPLAY PANEL #1 DENTIST RECOMMENDED BRAND FOR STRENGTHENING ENAMEL ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH MINT BURST 33.8 oz (1 L) #1 DENTIST RECOMMENDED BRAND FOR STRENGTHENING ENAMEL ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH MINT BURST 33.8 oz (1 L)
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 8 / 20250723
- 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.