Active Ingredients
Belladonna 6X†
Euphrasia officinalis (Eyebright) 6X
Hepar sulphuris 12X
Thuja 15X
Childrens Pink Eye Relief
FDA Label NDC 53799-369
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Similasan Ag for the product Childrens Pink Eye Relief (NDC 53799-369). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses*, warnings, if pregnant, trying to get pregnant or breast feeding,, keep out of reach of children., do not use:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Similasan
Children’s
Pink Eye
Relief
STERILE EYE DROPS
10 ml / 0.33 fl oz
Principal Display Panelsimilasanchildren’s Pink Eyereliefsterile Eye Drops10 mL / 0.33 Fl Oz (Childrens Pink Eye Relief 01)
* Please review the disclaimer below.
