MEDACTIVE ORAL RELIEF- spray spray

MedActive Oral Relief by

Drug Labeling and Warnings

MedActive Oral Relief by is a Otc medication manufactured, distributed, or labeled by Integrate Oral Care, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Glycerin 6% (prediluted)

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 swwallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes.

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 or 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 cuases no harm.

INACTIVE INGREDIENT

Inactive Ingredients

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

QUESTIONS

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NEW 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)

INGREDIENTS AND APPEARANCE

MEDACTIVE ORAL RELIEF 
spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49741-1019
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	29.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)	1 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	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
Shape		Size
Flavor	VANILLA (Vanillamint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49741-1019-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/31/2015

Labeler - Integrate Oral Care, LLC. (063540457)

Registrant - Integrate Oral Care, LLC. (063540457)