HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20%- hyaluronic acid sodium salt 1% / tacrolimus 0.1% / urea 20% cream 
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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HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20%

Directions for use

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Sincerus Florida, LLC. Adverse reactions

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Active, inactive

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NDC 72934- 2097-2 HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS USP 0.1% / UREA USP 20%. Cream 30gm.

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HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20% 
hyaluronic acid sodium salt 1% / tacrolimus 0.1% / urea 20% cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-2097
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA20 g  in 100 g
HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM1 g  in 100 g
TACROLIMUS (UNII: WM0HAQ4WNM) (TACROLIMUS ANHYDROUS - UNII:Y5L2157C4J) TACROLIMUS ANHYDROUS0.1 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-2097-230 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(72934-2097)

Revised: 5/2019
Document Id: 89036512-64f7-224b-e053-2a95a90a8068
Set id: 89036512-64f6-224b-e053-2a95a90a8068
Version: 1
Effective Time: 20190516
 
Sincerus Florida, LLC