Label: GENTEAL MILD TO MODERATE- hypromellose 2910 (4000 mpa.s) liquid
- NDC Code(s): 0078-0518-16, 0078-0518-24
- Packager: Novartis Pharmaceutical Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- INDICATIONS & USAGE SECTION
- Relieves dryness of the eye.
- Temporarily relieves discomfort due to minor irritations of the eye or from exposure to wind and sun.
- As a protectant against further irritation.
- WARNINGS SECTION
For external use only.Close
- OTC - DO NOT USE SECTION
Do not use
- if solution changes color or becomes cloudy
- if you are sensitive to any ingredient in this product
- OTC - WHEN USING SECTION
When using this product do not touch tip of container to any surface. Replace cap after using.Close
- OTC - STOP USE SECTION
Stop use and ask a doctor if you experience any of the following:
- eye pain
- changes in vision
- continued redness or irritation of the eye
- condition worsens or persists for more than 72 hours
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.Close
- DOSAGE & ADMINISTRATION SECTION
Put 1 or 2 drops in the affected eye(s) as needed.Close
- OTHER SAFETY INFORMATION
Store between 15°- 25°C (59°- 77°F).Close
- INACTIVE INGREDIENT SECTION
Boric acid, phosphonic acid, potassium chloride, purified water, sodium chloride and sodium perborate. May contain hydrochloric acid and / or sodium hydroxide to adjust pH.Close
- OTC - QUESTIONS SECTION
In the U.S.,call toll-free 1-866-393-6336;Close
Serious side effects associated with use of this product may be reported to this telephone number.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Mild to Moderate
Dry Eye Relief
LUBRICANT EYE DROPS
Fast, Soothing Relief
STERILE 15 mL (0.5 fl oz)
- INGREDIENTS AND APPEARANCE
GENTEAL MILD TO MODERATE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0078-0518 Route of Administration OPHTHALMIC DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hypromellose 2910 (4000 Mpa.s) (Hypromellose 2910 (4000 Mpa.s)) Hypromellose 2910 (4000 Mpa.s) 0.003 L in 1 L Inactive Ingredients Ingredient Name Strength Boric Acid Phosphonic Acid Potassium Chloride Water Sodium Chloride Sodium Perborate Hydrochloric Acid Sodium Hydroxide Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0078-0518-24 .015 L in 1 BOTTLE, DROPPER 2 NDC:0078-0518-16 .025 L in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 09/14/2009 Labeler - Novartis Pharmaceutical Corporation (002147023) Establishment Name Address ID/FEI Business Operations EXCELVISION AG 482198285 MANUFACTURE(0078-0518)