HYDROCORTISONE 0.5% / HYDROQUINONE 8% / TRETINOIN 0.025%- hydrocortisone 0.5% / hydroquinone 8% / tretinoin 0.025% emulsion 
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.

----------

HYDROCORTISONE 0.5% / HYDROQUINONE 8% / TRETINOIN 0.025%

Directions for use

d

Sincerus Florida, LLC adverse reactions

c

Active, inactive

c

NDC 72934-6107-2 HYDROCORTISONE USP 0.5% / HYDROQUINONE USP 8% / TRETINOIN USP 0.025%. Emulsion 30 gm

f

HYDROCORTISONE 0.5% / HYDROQUINONE 8% / TRETINOIN 0.025% 
hydrocortisone 0.5% / hydroquinone 8% / tretinoin 0.025% emulsion
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-6107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.5 g  in 100 g
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE8 g  in 100 g
TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R) TRETINOIN0.025 g  in 100 g
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-6107-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/01/2019
Labeler - Sincerus Florida, LLC (080105003)
Establishment
NameAddressID/FEIBusiness Operations
Sincerus Florida, LLC080105003manufacture(72934-6107)

Revised: 4/2019
Document Id: 874c4086-18fd-436b-e053-2a95a90afda2
Set id: 874c4086-18fc-436b-e053-2a95a90afda2
Version: 1
Effective Time: 20190424
 
Sincerus Florida, LLC