Application Nr Approved Date Route Status External Links
NDA022436 2009-07-31 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Xerese, A Combination Of Acyclovir, A Herpes Simplex Virus Nucleoside Analog Dna Polymerase Inhibitor, And Hydrocortisone, A Corticosteroid, Is Indicated For The Early Treatment Of Recurrent Herpes Labialis (cold Sores) To Reduce The Likelihood Of Ulcerative Cold Sores And To Shorten The Lesion Healing Time In Adults And Children (6 Years Of Age And Older). Xerese, A Combination Of Acyclovir, A Herpes Simplex Virus Nucleoside Analog Dna Polymerase Inhibitor, And Hydrocortisone, A Corticosteroid, Is Indicated For The Early Treatment Of Recurrent Herpes Labialis (cold Sores) To Reduce The Likelihood Of Ulcerative Cold Sores And To Shorten The Lesion Healing Time In Adults And Children (6 Years Of Age And Older). (1)

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Cetostearyl Alcohol CETOSTEARYL ALCOHOL Unresolved
2. Mineral Oil MINERAL OIL Unresolved
3. Poloxamer 188 POLOXAMER 188 Unresolved
4. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Isopropyl Myristate ISOPROPYL MYRISTATE Molecular
6. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
7. Citric Acid Monohydrate CITRIC ACID MONOHYDRATE Molecular

Active Ingredients ( 2 Total)

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