ACYCLOVIR - acyclovir cream 
Zydus Lifesciences Limited

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Acyclovir Cream, for topical use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1808-5 in tube of 5 g

Acyclovir Cream, 5%

Rx only

2 g

tube label
carton label
ACYCLOVIR 
acyclovir cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1808
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACYCLOVIR (UNII: X4HES1O11F) (ACYCLOVIR - UNII:X4HES1O11F) ACYCLOVIR50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (WHITE TO OFF WHITE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1808-21 in 1 CARTON03/03/2023
12 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70771-1808-51 in 1 CARTON03/03/2023
25 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20677003/03/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited650650802ANALYSIS(70771-1808) , MANUFACTURE(70771-1808)

Revised: 3/2023
Document Id: 4f3b08de-3446-4178-91d8-3d1a0d210034
Set id: bb956f2b-627a-49bd-b258-4aac21d64b9a
Version: 1
Effective Time: 20230302
 
Zydus Lifesciences Limited