Prescription Drug Information: DAPSONE 8.5% / NIACINAMIDE 2% / SPIRONOLACTONE 5%

DAPSONE 8.5% / NIACINAMIDE 2% / SPIRONOLACTONE 5%- spironolactone, dapsone and niacinamide gel
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.

Directions for use

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Sincerus Florida, LLC. Adverse reactions

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Active, inactive

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NDC 72934-1064-2 DAPSONE USP 8.5% / NIACINAMIDE USP 2% / SPIRONOLACTONE USP 5%. Gel 30gm

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DAPSONE 8.5% / NIACINAMIDE 2% / SPIRONOLACTONE 5%
dapsone 8.5% / niacinamide 2% / spironolactone 5% gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72934-1064
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPIRONOLACTONE (SPIRONOLACTONE) SPIRONOLACTONE 5 g in 100 g
DAPSONE (DAPSONE) DAPSONE 8.5 g in 100 g
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 2 g in 100 g
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72934-1064-2 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 05/10/2019
Labeler — Sincerus Florida, LLC (080105003)
Establishment
Name Address ID/FEI Operations
Sincerus Florida, LLC 080105003 manufacture (72934-1064)

Revised: 05/2019 Sincerus Florida, LLC

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