Label: JULIE COLD SORE TREATMENT- docosanol cream
- NDC Code(s): 82791-362-01
- Packager: Julie Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 12, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
JULIE COLD SORE TREATMENT
docosanol creamProduct 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 04/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA217090 04/01/2024 Labeler - Julie Products Inc (118628472) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 878100017 manufacture(82791-362) , analysis(82791-362)
