HYDROCORTISONE 1% / HYDROQUINONE 8% / TRETINOIN 0.05%- hydrocortisone 1% / hydroquinone 8% / tretinoin 0.05% 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.

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HYDROCORTISONE 1% / HYDROQUINONE 8% / TRETINOIN 0.05%

Directions for use

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Sincerus Florida, LLC. Adverse reactions

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Active, inactive

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NDC 72934- 6109-2 HYDROCORTISONE USP 1% / HYDROQUINONE USP 8% / TRETINOIN USP 0.05%. Emulsion 30 gm.

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HYDROCORTISONE 1% / HYDROQUINONE 8% / TRETINOIN 0.05% 
hydrocortisone 1% / hydroquinone 8% / tretinoin 0.05% emulsion
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-6109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE8 g  in 100 g
TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R) TRETINOIN0.05 g  in 100 g
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-6109-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/20/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/20/2019
Labeler - Sincerus Florida, LLC (080105003)
Establishment
NameAddressID/FEIBusiness Operations
Sincerus Florida, LLC080105003manufacture(72934-6109)

Revised: 5/2019
Document Id: 8956fd48-12e9-d41a-e053-2995a90ae63e
Set id: 8956fd48-12e8-d41a-e053-2995a90ae63e
Version: 1
Effective Time: 20190521
 
Sincerus Florida, LLC