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西药 · 美国药品标签原文

Gelato Homecare

STANNOUS FLUORIDE

Gelato Homecare · Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.。此记录对应特定产品,标签收录不代表所有用途获批。

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

Gelato Homecare Stannous Fluoride GLYCERIN WATER CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) CARBOXYMETHYLCELLULOSE SODIUM MALIC ACID XANTHAN GUM STANNOUS FLUORIDE FLUORIDE ION Red Berry Cloudy

活性成分 / Active ingredient

Active Ingredient Stannous Fluoride 0.4%

用途 / Purpose

Purpose Fluoride preventive treatment gel

适应证 / Indications and usage

Uses Home Care is a stable fluoride gel for home use. Aids in the prevention of dental decay.

警告 / Warnings

Warnings 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 toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using. This product 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. This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.

儿童安全 / Keep out of reach of children

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.

用法用量原文 / Dosage and administration

Directions Adults and children 6 years of age and older: Twist off cap to remove foil seal. 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 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.

储存 / Storage and handling

Other Information Store at controlled room temperature 59° - 86°F (15° - 30°C).

辅料 / Inactive ingredients

Inactive Ingredients Carbopol, Flavor, Glycerine, Malic Acid, Sodium Carboxymethylcellulose, Water, Xanthan Gum.

questions

Questions or comments? 1-800-333-3131 or www.keystoneind.com

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来源、版本与许可

资料类型
美国药品标签原文
版本
8 / 20240422
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.
核对原始来源