AEROFLAT- dimethicone capsule, liquid filled 
Innova Softgel LLC

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Principal Display Panel - Aeroflat Box Label

INNOVA SOFTGEL, LLC.

14193 S.W. 119th AVENUE

MIAMI, FL 33186

InnovaGel™

MADE IN THE U.S.A.

Customer Name: LABORATORIO COFASA, S.A.

NDC Number XXXXXXXX

MANUFACTURED DATE: <Empty>

Bulk Expiration Date:

TBD

Product Code:

MSU0068P

Batch #:

0000000

Box: 0

Product: AEROFLAT 125 mg Capsulas Blandas
(Simeticona 125 mg)

Customer Code: 21032

FOR P.O. N/A

Shape/Size: Oval/2

Quantity Per Box: 30,000

Softgels

Rev. # 2

Bulk product should be repackaged within 90 days of receipt.

Bulk product for further processing, packaging, labeling in compliance
with all federal standards.

Operator:

XX

PLEASE NOTE: Do no transport or store
below 59 degrees F or above 86 degrees
F. Exposure to temperature outside these
limits or humid condition may damage the
content of the box.

Principal Display Panel - Aeroflat Box Label
AEROFLAT 
dimethicone capsule, liquid filled
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:70578-8009
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone125 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
D&C Red NO. 33 (UNII: 9DBA0SBB0L)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorred (red) Scoreno score
ShapeCAPSULE (CAPSULE) Size10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70578-8009-130000 in 1 BOX09/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only09/01/2017
Labeler - Innova Softgel LLC (080096294)
Establishment
NameAddressID/FEIBusiness Operations
Innova Softgel LLC080096294MANUFACTURE(70578-8009)

Revised: 8/2017
 
Innova Softgel LLC