MEDACTIVE ORAL RELIEF- lozenge lozenge 
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.

----------

Active Ingredient (in each lozenge)

Pectin 2.8 mg

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.

Keep out of the reach of children.

Directions

Use as needed, up to 8 lozenges per day, or as directed by a dentist or doctor.

Other Information

acesulfame potassium,. citric acid, dimethicone, FD&C Yellow No. 5, flavor (includes Spilanthes Extract), isomalt, malic acid, poloxamer 338, sucralose, water

Questions?

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

Lozenge LemonLime

MedActive® Oral Relief Lozenges

For Relief of Oral Discomfort

with ULTRAMULSION® & Spilanthes Extract

LemonLime

Oral Demulcent

Pectin 2.8mg

NDC 49741-1009-2

20 Lozenges

MEDACTIVE ORAL RELIEF 
lozenge lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49741-1009
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN2.8 mg
Inactive Ingredients
Ingredient NameStrength
MALIC ACID (UNII: 817L1N4CKP)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOMALT (UNII: S870P55O2W)  
POLOXAMER 338 (UNII: F75JV2T505)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColoryellowScoreno score
ShapeOVALSize22mm
FlavorLEMON (LemonLime) Imprint Code None
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49741-1009-220 in 1 BOX08/31/2015
1NDC:49741-1009-11 in 1 CELLO PACK; Type 0: Not a Combination Product
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: 12/2022
Document Id: f113885a-960c-dc90-e053-2a95a90ad0ac
Set id: 2bd43c6c-93ae-1e94-e054-00144ff88e88
Version: 12
Effective Time: 20221230
 
Integrate Oral Care, LLC.