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MedActive Oral Relief by Integrate Oral Care, LLC.

Medically reviewed on November 22, 2017

Dosage form: spray
Ingredients: GLYCERIN 29.5mg in 1mL
Labeler: Integrate Oral Care, LLC.
NDC Code: 49741-1016

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Glycerin 6% (prediluted)

Purpose

Oral Demulcent

Uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

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.

Keep out of the reach of children.

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 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 Ingredients

dimethicone, EDTA, flavor (includes Spilanthes Extract), poloxamer 407, potassium sorbate, sodium saccharin, sucralose, water, xanthan gum, xylitol

Questions or comments?

Call toll-free 1-866-887-4867 or visit www.integrateoralcare.com

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)

MEDACTIVE ORAL RELIEF 
spray spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49741-1016
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (GLYCERIN) GLYCERIN29.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLOXAMER 4071 mg  in 1 mL
SUCRALOSE1 mg  in 1 mL
DIMETHICONE1 mg  in 1 mL
EDETIC ACID1 mg  in 1 mL
SACCHARIN SODIUM1 mg  in 1 mL
WATER1 mg  in 1 mL
XYLITOL1 mg  in 1 mL
XANTHAN GUM1 mg  in 1 mL
POTASSIUM SORBATE1 mg  in 1 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorFRUIT (Natural Spring) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49741-1016-129.5 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/31/2015
Labeler - Integrate Oral Care, LLC. (063540457)
Registrant - Integrate Oral Care, LLC. (063540457)

 
Integrate Oral Care, LLC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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