MEDACTIVE ORAL RELIEF- spray spray 
Integrate Oral Care, LLC.

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.

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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 swwallowed, 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.

Other Information

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

Spray VanillamintNEW Vanillamint Flavor

MedActive® Oral Relief Spray

with ULTRAMULSION® & Spilanthes Extract

For Relief of Oral Discomfort

Oral Demulcent

Glycerin 6%

NDC 49741-101901

1 FL. OZ. (29.5mL)

MEDACTIVE ORAL RELIEF 
spray spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49741-1019
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN29.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 1 mg  in 1 mL
XYLITOL (UNII: VCQ006KQ1E) 1 mg  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) 1 mg  in 1 mL
EDETIC ACID (UNII: 9G34HU7RV0) 1 mg  in 1 mL
POLOXAMER 407 (UNII: TUF2IVW3M2) 1 mg  in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 1 mg  in 1 mL
SUCRALOSE (UNII: 96K6UQ3ZD4) 1 mg  in 1 mL
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 1 mg  in 1 mL
XANTHAN GUM (UNII: TTV12P4NEE) 1 mCi  in 1 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorVANILLA (Vanillamint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49741-1019-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/31/2015
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)

Revised: 12/2021
Document Id: d4645044-3df7-d950-e053-2995a90af60c
Set id: 18dfd189-b861-19bf-e054-00144ff88e88
Version: 12
Effective Time: 20211230
 
Integrate Oral Care, LLC.