FDA Label for Childrens Allergy Eye Relief

View Indications, Usage & Precautions

Childrens Allergy 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



Apis 6X      

Euphrasia officinalis (Eyebright) 6X

Pulsatilla 6X

Sabadilla 6X


Purpose



burning, itching, swelling

redness, swelling, watering

itching, hay fever, watering, eye complaints in children

watering, redness of lids


Uses*



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

• itching      

• burning

• redness of eyes and lids

• excessive watering


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 a 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 age 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


Principal Display Panel



NDC 59262-370-11
Similasan
Children’s
Allergy
Eye Relief
STERILE EYE DROPS
10 ml / 0.33 fl oz


* Please review the disclaimer below.