Otc - Active Ingredient
Active Ingredient
Glycerin 6% (prediluted)
Medactive Oral Relief
FDA Label NDC 49741-1016
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 Oral Relief (NDC 49741-1016). 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 - Purpose
Purpose
Oral Demulcent
Indications & Usage
Uses
For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.
Warnings
Warnings
Sore Throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.
If an excessive amount of spray is accidentally swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
Dosage & Administration
Directions
Use as needed or as directed by a dentist or doctor.
- Adults and children 2 years of age and older: Hold bottle upright. Gently press down on spray and apply directly to affected areas in the mouth, approximately 3-4 times per application. Do not rinse out.
- Children under 12 years of age: Should be supervised in the use of this product.
- Children under 2 years of age: Consult a dentist or doctor.
Other Safety Information
Other Information
- Store at room temperature. Safe to swallow.
- Do not use if safety sleeve or label is damaged prior to first use. Do not push down on spray rapidly or excessively, as it may cause blockage.
- You may experience a slight, temporary tingle sensation upon initial use; this is normal and causes no harm.
Inactive Ingredient
Inactive Ingredients
dimethicone, EDTA, flavor (includes Spilanthes Extract), poloxamer 407, potassium sorbate, sodium saccharin, sucralose, water, xanthan gum, xylitol
Otc - Questions
Questions or comments?
Call toll-free 1-866-887-4867 or visit www.integrateoralcare.com
Package Label.Principal Display Panel
Oral Relief Spray
NEW Natural Spring Flavor
MedActive® Oral Relief Spray
with ULTRAMULSION® & Spilanthes Extract
For Relief of Oral Discomfort
Oral Demulcent
Glycerin 6%
NDC 49741-1016-1
1 FL.OZ. (29.5 mL)
Spray Natural Spring (Spr Ns Demulcent)
* Please review the disclaimer below.
