FDA Label for Childrens Pink Eye Relief
View Indications, Usage & Precautions
Childrens Pink Eye Relief Product Label
The following document was submitted to the FDA by the labeler of this product Similasan Corporation. 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†
Euphrasia officinalis (Eyebright) 6X
Hepar sulphuris 12X
Thuja 15X
Purpose
dryness, redness, burning
redness, burning, watering
sensation of grittiness, stinging
irritation
Uses*
According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:
• redness of the eyes
• irritation, dryness, and burning
• sensation of grittiness
• excessive watering (clear)
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.
• Contact wearers: consult physician prior to using.
If Pregnant, Trying To Get Pregnant Or Breast Feeding,
ask a health professional before use.
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:
• the child experiences eye pain or changes in vision
• symptoms worsen or persist for more than 72 hours
Directions
For 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 1 to 2 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
†containing 0.000002% alkaloids calculated as hyoscyamine
Principal Display Panel
NDC 59262-369-11
Similasan
Children’s
Pink Eye
Relief
STERILE EYE DROPS
10 ml / 0.33 fl oz
* Please review the disclaimer below.