FDA Label for Leader Advanced Formula
View Indications, Usage & Precautions
Leader Advanced Formula Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients Purpose
Dextran 70 0.1%................................................................Lubricant
Polyethylene glycol 400 1%.................................................Lubricant
Povidone 1%......................................................................Lubricant
Tetrahydrozoline HCL 0.05%...............................................Redness reliever
Otc - Purpose
Uses
- for the relief of redness of the eyes due to minor eye irritations
- for use as a protectant against further irritation or to relieve dryness of the eye
Warnings
Warnings
Ask a doctor before use if you have narrow angle glaucoma
Otc - When Using
When using this product
- pupils may become enlarged temporarily
- overuse may cause more eye redness
- remove contact lenses before using
- do not use if this solution changes color or becomes cloudy
- do not touch tip of container to any surface to avoid contamination
- replace cap after each use
Otc - Stop Use
Stop use and ask a doctor if
- you feel eye pain
- changes in vision occur
- redness or irritation of the eye lasts
- condition worsens or lasts more than 72 hours
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Directions
- put 1 to 2 drops in the affected eye(s) up to 4 times daily
- children under 6 years of age: ask a doctor
Storage And Handling
Other information
some users may experience a brief tingling sensation
store at 15o to 25oC (59o to 77oF)
Inactive Ingredient
Inactive ingredients:
benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, and sodium borate
Dosage & Administration
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
CIN 3256021
www.myleader.com
1-800-200-6313
Package Label.Principal Display Panel
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