说明与适用边界
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spl product data elements
OMNI Stannous Fluoride Stannous Fluoride Fluoride Ion Ascorbic Acid Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) Anhydrous Citric Acid Glycerin Trolamine MINT
spl unclassified section
Drug Facts
活性成分 / Active ingredient
Active ingredient Stannous fluoride 0.4% w/w (0.12% w/v fluoride ion)
用途 / Purpose
Purpose Anticavity
适应证 / Indications and usage
Use Aids in the prevention of dental decay
警告 / Warnings
Warnings This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using. Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
儿童安全 / Keep out of reach of children
This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using. Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
用法用量原文 / Dosage and administration
Directions Adults and children 6 years of age and older: Use a pea-sized (.25g) dose 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 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.
其他安全资料 / Other safety information
Other information Do not freeze or expose to extreme heat. Do not use if tamper evident seal on top of box is broken or removed.
辅料 / Inactive ingredients
Inactive ingredients ascorbic acid, carbomer, citric acid, flavor, glycerin, triethanolamine
questions
Questions or comments? call toll free M-F 9am to 5pm EST/EDT at 1-800-634-2249
package label principal display panel
Principle Display Panel Mint NDC 48878-4061-3 3M ESPE OMNI Gel™ 0.4% Stannous Fluoride Preventive Treatment Gel IMPORTANT: Read Directions thoroughly. Contents: NET WT. 4.3 oz (121.9 g) Principle Display Panel
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 7 / 20240801
- 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.