VETNIQUE - OTICBLISS MEDICATED EAR DROPS (80547-113) - DELIST

OTICBLISS MEDICATED EAR DROPS by

Drug Labeling and Warnings

OTICBLISS MEDICATED EAR DROPS by is a Animal medication manufactured, distributed, or labeled by Vetnique Labs Llc, CUSTOM VET SERVICES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTICBLISS MEDICATED EAR DROPS- hydrocortisone solution 
Vetnique Labs Llc

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.

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VETNIQUE - OTICBLISS MEDICATED EAR DROPS (80547-113) - DELIST

Active Ingredients

HYDROCORTISONE 1%

OTICBLISS MEDICATED EAR DROPS 
hydrocortisone solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 80547-113
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80547-113-02	51.75 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/21/2022	06/21/2022

Labeler - Vetnique Labs Llc (945367014)

Establishment
Name	Address	ID/FEI	Business Operations
CUSTOM VET SERVICES LLC		619511483	manufacture, api manufacture

Revised: 10/2022

Document Id: 4bbbff0f-cace-4758-825d-7d35c8ceddb9

50577-6

Set id: 56bc9e92-fd47-4a28-8e63-a8e4832045b8

Version: 4

Effective Time: 20221018