Prescription Drug Information: CALCIPOTRIENE 0.005% / DICLOFENAC SODIUM 3% / HYALURONIC ACID SODIUM SALT 2% / NIACINAMIDE 2%

CALCIPOTRIENE 0.005% / DICLOFENAC SODIUM 3% / HYALURONIC ACID SODIUM SALT 2% / NIACINAMIDE 2%- calcipotriene, diclofenac sodium, hyaluronate sodium and niacinamide 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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NDC 72934-2030-2 CALCIPOTRIENE USP 0.005% / DICLOFENAC SODIUM USP 3% / HYALURONIC ACID SODIUM SALT 2% / NIACINAMIDE USP 2%. Cream 30 gm

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CALCIPOTRIENE 0.005% / DICLOFENAC SODIUM 3% / HYALURONIC ACID SODIUM SALT 2% / NIACINAMIDE 2%
calcipotriene 0.005% / diclofenac sodium 3% / hyaluronic acid sodium salt 2% / niacinamide 2% cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72934-2030
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIPOTRIENE (CALCIPOTRIENE) CALCIPOTRIENE 0.005 g in 100 g
DICLOFENAC SODIUM (DICLOFENAC) DICLOFENAC SODIUM 3 g in 100 g
HYALURONATE SODIUM (HYALURONIC ACID) HYALURONATE SODIUM 2 g in 100 g
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 2 g in 100 g
Product Characteristics
Color white (clear cream) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72934-2030-2 30 g in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/07/2019
Labeler — Sincerus Florida, LLC (080105003)
Establishment
Name Address ID/FEI Operations
Sincerus Florida, LLC 080105003 manufacture (72934-2030)

Revised: 05/2019 Sincerus Florida, LLC

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