BENZOYL PEROXIDE 5% / CLINDAMYCIN 1% / NIACINAMIDE 2% / SPIRONOLACTONE 2% / TRETINOIN 0.05%- benzoyl peroxide 5% / clindamycin 1% / niacinamide 2% / spironolactone 2% / tretinoin 0.05% 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.

----------

BENZOYL PEROXIDE 5% / CLINDAMYCIN 1% / NIACINAMIDE 2% / SPIRONOLACTONE 2% / TRETINOIN 0.05%

Directions for use

b

Sincerus Florida, LLC adverse reactions.

l

Active, inactive

b

NDC 72934-1016-2
BENZOYL PEROXIDE 5% / CLINDAMYCIN 1% / NIACINAMIDE 2% / SPIRONOLACTONE 2% / TRETINOIN 0.05%
GEL 30 gm

j

BENZOYL PEROXIDE 5% / CLINDAMYCIN 1% / NIACINAMIDE 2% / SPIRONOLACTONE 2% / TRETINOIN 0.05% 
benzoyl peroxide 5% / clindamycin 1% / niacinamide 2% / spironolactone 2% / tretinoin 0.05% gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72934-1016
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g  in 100 g
CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN PHOSPHATE 1 g  in 100 g
TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R) TRETINOIN 0.05 g  in 100 g
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 2 g  in 100 g
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232) SPIRONOLACTONE 2 g  in 100 g
Product Characteristics
Color yellow Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:72934-1016-2 30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/03/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/03/2019
Labeler - Sincerus Florida LLC (080105003)
Establishment
Name Address ID/FEI Business Operations
Sincerus Florida LLC 080105003 manufacture(72934-1016)

Revised: 5/2019
Document Id: 87ed3aff-1a1f-c070-e053-2a95a90af490
Set id: 87ed3aff-1a1e-c070-e053-2a95a90af490
Version: 1
Effective Time: 20190502
 
Sincerus Florida LLC