FDA Label for Pink Eye

View Indications, Usage & Precautions

Pink Eye Product Label

The following document was submitted to the FDA by the labeler of this product Trp Company. 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 IngredientsPurpose
Aconite HPUS 6xInflammation, Redness
Apis HPUS 6xSwelling
Argentum Nit. HPUS 12xBurning
Euphrasia HPUS 6xWatering
Natrum Arsenicicum HPUS 11xGrittiness, Overnight crusting

The letters HPUS indicate that the components of this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Uses*



According to homeopathic indications these ingredients temporarily relieve minor symptoms such as:
• Redness • Burning sensations • Watering • Inflammation • Sensation of grittiness and overnight crusting after diagnosis by a physician. * These statements are based on traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.


Warnings



USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN.

For External Use Only.

  • Children under 2 years of age should be seen by a physician.
  • Initial worsening of symptoms may occur.
  • Physician should always be consulted to rule out serious conditions.
    • Contact lens wearers consult physician prior to using.
    • To avoid contamination - do not touch tip to any surface.
    • Replace cap after every use.
    • Use within 30 days of opening.
    • EXPIRATION DATE ONLY REFERS TO THE UNOPENED BOTTLE.
    • The use of this container by more than one person may spread infection.

Otc - Pregnancy Or Breast Feeding



  • If pregnant or breast-feeding, ask a health professional before use.

Do Not Use:



  • If solution changes color or becomes cloudy.
  • If you frequently contract infections that do not clear up easily.
  • If you experience eye pain or changes in vision.
  • If you are experiencing a thick, white, yellow, or green discharge that forms a crust on the eyelid.

Stop Use And Ask A Doctor If:



  • You experience eye pain, changes in vision, continued redness or irritation of the eye.
  • In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
  • The condition worsens.
  • The condition persists for more than 72 hours.

Keep Out Of Reach Of Children



• In case of accidental ingestion, get medical help or contact a Poison Control Center right away.


Directions



For adults and children age 2 and over. Squeeze 1-3 drops in the eye. Use several times per day as needed. • Use within 30 days of opening. Expiration date only refers to unopened bottle.


Other Information



Non-prescription drug products cannot treat infections. You may get temporary relief of redness, burning, watering, inflammation, sensation of grittiness and overnight crusting with Pink Eye™ Relief Homeopathic Sterile Eye Drops.

  • Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects. PinkEye™; Homeopathic Sterile Eye Drops are homeopathic dilutions: see www.trpcompany.com for details.
  • Store at room temperature 15° to 30° C (59° to 84° F).
  • Keep bottle tightly closed

Inactive Ingredients



Benzalkonium Chloride (preservative), Citrates, Purified water, Sodium Chloride, Sodium Phosphate DiBasic, Sodium Phosphate Monobasic


Questions Or Comments?



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