FDA Label for Pink Eye Relief

View Indications, Usage & Precautions

Pink Eye Relief Product Label

The following document was submitted to the FDA by the labeler of this product Similasan Ag. 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.

Active Ingredients



Belladonna 6X†

†containing 0.000002% alkaloids calculated as hyoscyamine

Euphrasia officinalis (Eyebright) 6X

Hepar sulphuris 12X


Purpose



dryness, redness, burning, sensation of grittiness

watery discharge

redness, stinging


Uses*



According to homeopathic principles, the active ingredients in this product temporarily relieve minor eye symptoms:

• excessive watery (clear) discharge

• sensation of grittiness

• redness and burning


Warnings



• For external use only.

• Children under 2 years of age should be seen by a physician.

• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

• To avoid contamination, do not touch the tip of the bottle to any surface.

• To avoid contamination use within 30 days of opening. Expiration date only refers to unopened bottle.

• Replace cap tightly after every use.

• Contact lens wearers: consult physician prior to using.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Do Not Use:



• if the solution changes color or becomes cloudy


Stop Use And Ask A Doctor If:



• you experience eye pain or changes in vision

• symptoms worsen or persist for more than 72 hours

• you might have a serious underlying medical cause for an infection


Directions



For adults and children ages 2 and over:

• remove tamper-evident seal from neck of bottle

• twist cap off bottle

DON’T squeeze bottle, squeeze plastic tip to release 2-3 drops into eye

• apply as needed

• replace cap after use


Other Information



Active ingredients are manufactured according to homeopathic principles.


Inactive Ingredients



Borate buffer, Purified water, Silver sulfate (as preservative), Sodium nitrate


Questions?



Reach our representatives at 1-800-240-9780 or [email protected].
www.SimilasanUSA.com

For your protection do not use if tamper evident seal around neck of bottle is missing or broken.

*These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.


Principal Display Panel



NDC 53799-365-11
Similasan
Pink Eye Relief
10 mL/ 0.33 fl oz


* Please review the disclaimer below.