07d7fb43-8d3e-4d1f-b38d-e3caf28e9acf
07d7fb43-8d3e-4d1f-b38d-e3caf28e9acf
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Fluoride preventive treatment gel
Description
Stannous Fluoride 0.4%
Medication Information
Warnings and Precautions
Warnings
Uses
- Home Care is a stable fluoride gel for home use.
- Aids in the prevention of dental decay.
Purpose
Fluoride preventive treatment gel
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.
Other Information
Store at controlled room temperature 59° - 86°F (15° - 30°C).
Inactive Ingredients
Carbopol, Flavor, Glycerine, Malic Acid, Sodium Carboxymethylcellulose, Water, Xanthan Gum.
Description
Stannous Fluoride 0.4%
Section 50565-1
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.
Section 51945-4
Active Ingredient
Stannous Fluoride 0.4%
Questions Or Comments?
1-800-333-3131 or www.keystoneind.com
Structured Label Content
Warnings and Precautions (34071-1)
Warnings
Uses
- Home Care is a stable fluoride gel for home use.
- Aids in the prevention of dental decay.
Purpose
Fluoride preventive treatment gel
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.
Other Information
Store at controlled room temperature 59° - 86°F (15° - 30°C).
Inactive Ingredients
Carbopol, Flavor, Glycerine, Malic Acid, Sodium Carboxymethylcellulose, Water, Xanthan Gum.
Section 50565-1 (50565-1)
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.
Section 51945-4 (51945-4)
Active Ingredient
Stannous Fluoride 0.4%
Questions Or Comments? (Questions or comments?)
1-800-333-3131 or www.keystoneind.com
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:59.892271 · Updated: 2026-03-14T23:02:50.389879