GONIOVISC OPHTHALMIC LUBRICANT- hypromelloses solution/ drops 
HUB Pharmaceuticals, 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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GONIOVISC Hypromellose 2.5% Ophthalmic Lubricant Solution USP (Sterile)

ACTIVE INGREDIENTS:

Active Ingredients             Purpose

Hypromellose 25 mg (2.5%)......Lubricant

USE:

For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

WARNINGS:

  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.
  • If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.
  • Keep this and all drugs out of the reach of children.
  • In case of accidental ingestion,seek professional assistance or contact a Poison Control Center immediately.

DO NOT USE:

  • If solution changes color or becomes cloudy.

DIRECTIONS:

  • To open, twist cap to puncture sterile seal.
  • Remove cap.
  • Instill 1 or 2 drops in the affected eye(s) as needed.

INACTIVE INGREDIENTS:

Inactive Ingredients:

  • Boric Acid
  • Edetate Disodium
  • Sodium Borate
  • Water for Injection
  • Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.0-7.8)

Preservative:

  • Benzalkonium Chloride IP 0.02% v/v

OTHER INFORMATION:

  • Save carton for full directions and warnings.
  • Store at room temperature 15°-30°C (59°-86°F).
  • Do not freeze.
  • Do not use if imprinted seal on cap is torn, broken, or missing.

WARNINGS:

  • Keep this and all drugs out of the reach of children.

INDICATIONS:

For use as a lubricant to prevent further irritation or to relieve dryness of the eye

PACKAGE LABELS:

Label for Bottle

Image 1. Label for Bottle


Label for Box

Image 2. Label for Box

GONIOVISC  OPHTHALMIC LUBRICANT
hypromellose solution/ drops
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:17238-610
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPROMELLOSES (HYPROMELLOSES) HYPROMELLOSES0.025 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID0.0001 mg  in 1 mL
EDETATE DISODIUM0.0001 mg  in 1 mL
SODIUM BORATE0.0001 mg  in 1 mL
WATER 
HYDROCHLORIC ACID 
SODIUM HYDROXIDE 
BENZALKONIUM CHLORIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17238-610-151 in 1 BOX
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2011
Labeler - HUB Pharmaceuticals, LLC (611747945)

Revised: 4/2011
 
HUB Pharmaceuticals, LLC