Label: OTICBLISS MEDICATED EAR DROPS- hydrocortisone solution

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 21, 2022

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  • Active Ingredients

    HYDROCORTISONE 1%

  • PRINCIPAL DISPLAY PANEL

    01b LBL_OB-Drops-Label_6322

  • INGREDIENTS AND APPEARANCE
    OTICBLISS MEDICATED EAR DROPS 
    hydrocortisone solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:80547-114
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) (UNII: SBD1A2I75N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80547-114-0253.23 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/21/2022
    Labeler - Vetnique Labs Llc (945367014)
    Establishment
    NameAddressID/FEIBusiness Operations
    CUSTOM VET SERVICES LLC619511483manufacture, api manufacture