说明与适用边界
此页按所列地区、版本归档。标签内容可能更新，具体产品请核对原始来源；本站关联表示阅读线索，不表示药品与器械可兼容或可替换。
spl product data elements
Ionite H Stannous Fluoride STANNOUS FLUORIDE FLUORIDE ION CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) CITRIC ACID MONOHYDRATE GLYCERIN SODIUM HYDROXIDE WATER XYLITOL
活性成分 / Active ingredient
Active Ingredient Stannous fluoride, 0.4%
用途 / Purpose
Purpose Anticavity
适应证 / Indications and usage
Uses Aids in the prevention of dental cavities (caries).
警告 / Warnings
Warnings Keep out of reach of children. If more that used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not swallow. Supervision of children is required when using this product. Developing teeth of children under six years of age may become permanently discolored if excessive amounts are repeatedly swallowed.
Supervision of children is required when using this product. Developing teeth of children under six years of age may become permanently discolored if excessive amounts are repeatedly swallowed.
儿童安全 / Keep out of reach of children
Keep out of reach of children. If more that used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
禁用事项 / Do not use
Do not swallow.
用法用量原文 / Dosage and administration
Directions • This is not a toothpaste. Read directions carefully before using. • Adults and children 6 years of age and older: o Use once per day after brushing teeth thoroughly with toothpaste o Twist off cap to remove foil seal o Apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces. o Allow the gel to remain on your teeth for 1 minute o Spit out. Do not swallow o Do not eat, drink, or rinse for at least 30 minutes • Children under 6: consult a dentist or doctors
spl unclassified section
Other Information Store at room temperature 59 – 86°F (15 – 30°C) 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
Manufactured by Dharma Research, Inc. www.dharmaresearch.com 5220 N.W. 72 Avenue, Unit 15 Miami, FL 33166 1-877-833-3725
辅料 / Inactive ingredients
Inactive Ingredients Carbopol, citric acid, flavor, glycerin, sodium hydroxide, water, xylitol
package label principal display panel
Ionite H NDC 53045-271-04 Home Care 0.4% Stannous Fluoride Gel with Xylitol Anticavity Fluoride Preventative Treatment Gel Bubble Gum Made in USA Gluten Free Dye Free Reorder#: 56-00131 4.3 oz. (122 g) 20150802 271 SnF2 BubGm revB
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20231011
- 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.