Allergy Eye Relief
FDA Label NDC 53799-302

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 Allergy Eye Relief (NDC 53799-302). 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, keep out of reach of children., do not use:, stop use and ask a doctor if:, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Apis mellifica 6X

Euphrasia officinalis (Eyebright) 6X

Sabadilla 6X

Purpose

burning, itching, stinging

redness, swelling, watering

watering, redness of lids

Uses*

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

• itching

• burning

• excessive watering

  • redness of eyes and lids

Warnings

• For external use only.

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

• Use only if single-use dropper is intact.

• To avoid contamination, do not touch the tip of the dropper to any surface. Do not reuse. Once opened, discard.

• Contact lens wearers: consult a 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 solution changes color or becomes cloudy

Stop Use And Ask A Doctor If:

• symptoms worsen or persist for more than 72 hours

• you experience eye pain or changes in vision

Directions

For adults and children age 2 and over:

• remove a single-use dropper

• twist flat end with ball to remove

• squeeze plastic dropper to release 2-3 drops into eye and discard applicator

• apply as needed

• use a new dropper for every application

Other Information

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients

Phosphate buffer, Purified water

Questions?

Reach our representatives at 1-800-240-9780 or [email protected]

www.SimilasanUSA.com

Principal Display Panel

Allergy Eye
Relief
0.4 ml/0.014 fl oz each

Allergy Eyerelief0.4 mL/0.014 Fl Oz Each (Allergy Eye Relief Monodose 01)

Allergy Eyerelief0.4 mL/0.014 Fl Oz Each (Allergy Eye Relief Monodose 01)

* Please review the disclaimer below.