Label: OCLUVET NAC NUTRITIONAL LUBRICANT EYE DROPS solution/ drops

  • 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 July 22, 2024

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  • WARNINGS AND PRECAUTIONS

    Not for use in humans. Keep out of reach of children. Protective gloves should be used and care should be taken when handling the product to avoid skin and eye exposure and accidental ingestion. Accidental exposure may result in skin and eye irritation. Accidental ingestion may cause gastrointestinal disturbances and hypersensitivity reactions in humans.

    Warnings: Cease use and consult your veterinarian if the patient experiences eye redness or discomfort for more than 72 hours.Do not use if seal is broken. Do not touch the bottle tip to any surface during application. Do not share this container or the contents with others. Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions: Shake well before each use.Apply drop to the eye 3 times per day for 6 to 8 weeks or as directed by your veterinarian. To maintain ocular clarity, aooly 1 drop to the eye per day. See package insert for additional information.

  • ACTIVE INGREDIENT

    N-Acetyl-L-Carnosine

  • INACTIVE INGREDIENT

    Ingredients: Purified Water,Sodium Hydrogen Carbonate (as a buffering agent), N-Acetyl-L-Carnosine, purifiedL Carnosine, Glutathione, Cysteine Ascorbate, L-Taurine, Riboflavin Monophosphate, PropyleneGlycol(0.2%)

  • WARNINGS AND PRECAUTIONS

    Not for use in humans. Keep out of reach of children. Protective gloves should be used and care should be taken when handling the product to avoid skin and eye exposure and accidental ingestion. Accidental exposuremay result in skin and eye irritation. Accidental ingestion may cause gastrointestinal disturbances and hypersensitivity reactions in humans.

    Content of Labeling

  • PRINCIPAL DISPLAY PANEL

    Directions: Shake well before each use.Apply drop to the eye 3 times per day for 6 to 8 weeks or as directed by your veterinarian. To maintain ocular clarity, aooly 1 drop to the eye per day. See package insert for additional information. Ingredients: Purified Water,Sodium Hydrogen Carbonate (as a buffering agent), N-Acetyl-L-Carnosine, purifiedL Carnosine, Glutathione, Cysteine Ascorbate, L-Taurine, Riboflavin Monophosphate, PropyleneGlycol(0.2%) Warnings: Cease use and consult your veterinarian if the patient experiences eye redness or discomfort for more than 72 hours.Do not use if seal is broken. Do not touch the bottle tip to any surface during application. Do not share this container or the contents with others. Keep out of reach of children.

    The labeling shows as below:

    Content of Labeling

  • INGREDIENTS AND APPEARANCE
    OCLUVET NAC NUTRITIONAL LUBRICANT EYE DROPS 
    ocluvet nac nutritional lubricant eye drops solution/ drops
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86202-0090
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    N-ACETYLCARNOSINE (UNII: 0TPN86OQIF) (N-ACETYLCARNOSINE - UNII:0TPN86OQIF) N-ACETYLCARNOSINE1 mg  in 16 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    GLUTATHIONE (UNII: GAN16C9B8O)  
    CYSTEINE (UNII: K848JZ4886)  
    CALCIUM ASCORBATE (UNII: 183E4W213W)  
    TAURINE (UNII: 1EQV5MLY3D)  
    RIBOFLAVIN (UNII: TLM2976OFR)  
    RIBOFLAVIN SODIUM (UNII: 04SRR95RP8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86202-0090-116 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2024
    Labeler - AMBIENCE FAMILY INC (084561491)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMBIENCE FAMILY INC084561491manufacture, api manufacture