Medactive Patient Friendly
FDA Label NDC 49741-1007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Integrate Oral Care, Llc. for the product Medactive Patient Friendly (NDC 49741-1007). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Other Safety Information

→ Inactive Ingredient

→ Otc - Questions

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active ingredient

Stannous fluoride 0.1%

Otc - Purpose

Purpose

Cavity protection

Indications & Usage

Uses

Aids in the prevention of dental decay.

Warnings

When using this product, do not use longer than four weeks unless recommended by a medical doctor and/or dental professional.
If more than used for rinsing is swallowed, seek medical attention or contact a Poison Control Center immediately.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

Directions

Use immediately after preparing the rinse as follows:

Adults and children 6 years of age and older:

Place both thumbs on Blue Chamber No. 1 and Press down firmly to squeeze fluoride into Chamber No. 2.
Gently Shake.
Snap Tab to Open by bending at line on the cap. Dispense half of mixture into the mouth and Rinse for 30 seconds. Spit.
Gargle with remainder of mixture for 30 seconds. Spit.
Avoid any food or drinks for at least 15 minutes after use.

Children under 6 years of age:

Consult your medical doctor and/or dental professional

Other Safety Information

Other information

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 dental professional.
Do not refrigerate. Store at room temperature.

Inactive Ingredient

Inactive Ingredients

dimethicone, EDTA, FD&C Green No. 3, flavor (includes Spilathes Extract), glycerin, poloxamer 407, potassium sorbate, sodium saccharin, sorbitol, sucralose, water