JULIE COLD SORE TREATMENT- docosanol cream

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]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JULIE COLD SORE TREATMENT 
docosanol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82791-362
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCOSANOL (UNII: 9G1OE216XY) (DOCOSANOL - UNII:9G1OE216XY)	DOCOSANOL	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82791-362-01	2 g in 1 TUBE; Type 0: Not a Combination Product	07/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA217090	07/02/2024

Labeler - Julie Products Inc (118628472)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		878100017	manufacture(82791-362) , analysis(82791-362)