Julie Cold Sore Treatment by Julie Products Inc / APL HEALTHCARE LIMITED

Julie Cold Sore Treatment by

Drug Labeling and Warnings

Julie Cold Sore Treatment by is a Otc medication manufactured, distributed, or labeled by Julie Products Inc, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

JULIE COLD SORE TREATMENT- docosanol cream 
Julie Products Inc

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Dosage

Warnings

Inactive Ingredients

Indications

Children

Purpose

Active

JULIE COLD SORE TREATMENT 
docosanol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82791-362
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCOSANOL (UNII: 9G1OE216XY) (DOCOSANOL - UNII:9G1OE216XY) DOCOSANOL100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SUCROSE DISTEARATE (UNII: 33X4X4B90S)  
SUCROSE STEARATE (UNII: 274KW0O50M)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82791-362-012 g in 1 TUBE; Type 0: Not a Combination Product04/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21709004/01/202407/01/2024
Labeler - Julie Products Inc (118628472)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED878100017manufacture(82791-362) , analysis(82791-362)

Revised: 7/2024
Document Id: 1cfaad88-aa9e-a51f-e063-6294a90a5e6f
Set id: 113372a4-58de-f829-e063-6294a90a4eb1
Version: 2
Effective Time: 20240711
 
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