Ionite H Gel, Dentifrice
FDA Label NDC 53045-271

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dharma Research, Inc. for the product Ionite H (NDC 53045-271). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, otc - keep out of reach of children, otc - do not use, warnings, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Stannous fluoride, 0.4%

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities (caries).

Otc - 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.

Otc - Do Not Use

Do not swallow.

Warnings

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.

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

Other

Manufactured by Dharma Research, Inc.

www.dharmaresearch.com

5220 N.W. 72 Avenue, Unit 15

Miami, FL 33166

1-877-833-3725

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)

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