DAPSONE- dapsone gel 
Zydus Lifesciences Limited

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Dapsone Gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dapsone Gel, 7.5%

60 g

NDC 70771-1538-3

Zydus

Rx only

dapsone gel
Dapsone gel
DAPSONE 
dapsone gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1538
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302) DAPSONE75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ACRYLAMIDE (UNII: 20R035KLCI)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (off white to yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1538-21 in 1 CARTON05/10/2024
130 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:70771-1538-31 in 1 CARTON05/10/2024
260 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3NDC:70771-1538-81 in 1 CARTON05/10/2024
390 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21401905/10/2024
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited650650802ANALYSIS(70771-1538) , MANUFACTURE(70771-1538)

Revised: 5/2024
Document Id: ae448df2-611f-4d56-911f-11d01983726f
Set id: 8b63b653-0507-4f95-9bfa-70fd071e15a6
Version: 1
Effective Time: 20240509
 
Zydus Lifesciences Limited