042636cf-8b61-4022-b0a1-af09c06b145b
042636cf-8b61-4022-b0a1-af09c06b145b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Anticavity
Description
Stannous fluoride, 0.4%
Medication Information
Warnings and Precautions
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.
Uses
Aids in the prevention of dental cavities (caries).
Purpose
Anticavity
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
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
Inactive Ingredients
Carbopol, citric acid, flavor, glycerin, sodium hydroxide, water, xylitol
Description
Stannous fluoride, 0.4%
Section 42229-5
Manufactured by Dharma Research, Inc.
www.dharmaresearch.com
5220 N.W. 72 Avenue, Unit 15
Miami, FL 33166
1-877-833-3725
Section 50565-1
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.
Section 50570-1
Do not swallow.
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)
Active Ingredient
Stannous fluoride, 0.4%
Structured Label Content
Warnings and Precautions (34071-1)
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.
Uses
Aids in the prevention of dental cavities (caries).
Purpose
Anticavity
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
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
Inactive Ingredients
Carbopol, citric acid, flavor, glycerin, sodium hydroxide, water, xylitol
Section 42229-5 (42229-5)
Manufactured by Dharma Research, Inc.
www.dharmaresearch.com
5220 N.W. 72 Avenue, Unit 15
Miami, FL 33166
1-877-833-3725
Section 50565-1 (50565-1)
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.
Section 50570-1 (50570-1)
Do not swallow.
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)
Active Ingredient
Stannous fluoride, 0.4%
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:01:23.642960 · Updated: 2026-03-14T23:01:22.645369