BENZOYL PEROXIDE 5% / CLINDAMYCIN 1% / NIACINAMIDE 2% / SPIRONOLACTONE 2% / TRETINOIN 0.025%- benzoyl peroxide 5% / clindamycin 1% / niacinamide 2% / spironolactone 2% / tretinoin 0.025% 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.

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BENZOYL PEROXIDE 5% / CLINDAMYCIN 1% / NIACINAMIDE 2% / SPIRONOLACTONE 2% / TRETINOIN 0.025%

Directions for use

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Sincerus Florida, Adverse reactions

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Active, inactive

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NDC 72934-1015-2. BENZOYL PEROXIDE USP 5%, CLINDAMYCIN PHOSPHATE USP 1%, NIACINAMIDE USP 4% / SPIRONOLACTONE USP 2% / TRETINOIN USP 0.025%. Gel30gm.

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BENZOYL PEROXIDE 5% / CLINDAMYCIN 1% / NIACINAMIDE 2% / SPIRONOLACTONE 2% / TRETINOIN 0.025% 
benzoyl peroxide 5% / clindamycin 1% / niacinamide 2% / spironolactone 2% / tretinoin 0.025% gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 g
CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN PHOSPHATE1 g  in 100 g
TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R) TRETINOIN0.025 g  in 100 g
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 g
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232) SPIRONOLACTONE2 g  in 100 g
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-1015-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/04/2019
Labeler - Sincerus Florida, LLC (080105003)
Establishment
NameAddressID/FEIBusiness Operations
Sincerus Florida, LLC080105003manufacture(72934-1015)

Revised: 5/2019
Document Id: 8800b79f-5e6e-7002-e053-2995a90a9761
Set id: 8800b79f-5e6d-7002-e053-2995a90a9761
Version: 1
Effective Time: 20190503
 
Sincerus Florida, LLC