NIACINAMIDE 4% / TACROLIMUS 0.03%- niacinamide 4% / tacrolimus 0.03% ointment 
Sincerus Florida, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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NIACINAMIDE 4% / TACROLIMUS 0.03%

Directions for use

sd

Sincerus Florida, LLC. Adverse reactions

ss

Active, inactive

dwd

NDC 72934- 5158-2 NIACINAMIDE USP 4% / TACROLIMUS USP 0.03%. Ointment 30gm.

fd

NIACINAMIDE 4% / TACROLIMUS 0.03% 
niacinamide 4% / tacrolimus 0.03% ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-5158
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TACROLIMUS (UNII: WM0HAQ4WNM) (TACROLIMUS ANHYDROUS - UNII:Y5L2157C4J) TACROLIMUS ANHYDROUS0.03 g  in 100 g
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE4 g  in 100 g
Product Characteristics
Colorwhite (clear ointment) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-5158-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/17/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/17/2019
Labeler - Sincerus Florida, LLC (080105003)
Establishment
NameAddressID/FEIBusiness Operations
Sincerus Florida, LLC080105003manufacture(72934-5158)

Revised: 5/2019
Document Id: 8902e7d5-cdb1-1ca1-e053-2995a90a951f
Set id: 8902e7d5-cdb0-1ca1-e053-2995a90a951f
Version: 1
Effective Time: 20190516
 
Sincerus Florida, LLC