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

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

Inactive Ingredients

acesulfame potassium, citric acid, dimethicone, FD&C Yellow No. 6, flavor (includes Spilanthes Extract), isomalt, malic acid, poloxamer 338, sucralose, water.

Questions or comments?

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

Lozenge Orange Crème

MedActive® Oral Relief Lozenges

For Relief of Oral Discomfort

with ULTRAMULSION® & Spilanthes Extract

Orange Crème

Oral Demulcent

Pectin 2.8mg

NDC 49741-1011-2

20 Lozenges

MEDACTIVE ORAL RELIEF 
lozenge lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49741-1011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN2.8 mg
Inactive Ingredients
Ingredient NameStrength
ISOMALT (UNII: S870P55O2W)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MALIC ACID (UNII: 817L1N4CKP)  
POLOXAMER 338 (UNII: F75JV2T505)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colororange (Translucent Orange) Scoreno score
ShapeOVALSize22mm
FlavorORANGE (Orange Crème) Imprint Code None
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49741-1011-220 in 1 BOX08/31/2015
1NDC:49741-1011-11 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: f113fbfd-1a6c-ab93-e053-2a95a90a006c
Set id: 2b72623f-1642-6613-e054-00144ff8d46c
Version: 13
Effective Time: 20221230
 
Integrate Oral Care, LLC.