PINK EYE REMEDY- atropa belladonna, calcium sulfide, euphrasia stricta solution/ drops

Pink Eye Remedy by

Drug Labeling and Warnings

Pink Eye Remedy by is a Homeopathic medication manufactured, distributed, or labeled by Similasan AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Belladonna 6X†

Euphrasia officinalis (Eyebright) 6X

Hepar sulphuris 12X

Purpose

dryness, redness, burning, sensation of grittiness

watery discharge

redness, stinging

Uses*

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

excessive watery (clear) discharge

sensation of grittiness

redness and burning

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.

Replace cap tightly after every use.

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:

you experience eye pain or changes in vision

symptoms worsen or persist for more than 72 hours

you might have a serious underlying medical cause for an infection

Directions

For adults and 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 2-3 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?

1-800-240-9780

FOR YOUR PROTECTION, DO NOT USE IF TAMPER-EVIDENT SEAL AROUND NECT OF BOTTLE IS MISSING OR BROKEN

*THIS PRODUCT IS A HOMEOPATHIC REMEDY. AS SUCH, IT HAS NOT UNDERGONE REVIEW OR APPROVAL BY THE FDA AND THEREFORE HAS NOT BEEN DEMONSTRATED TO BE SAFE OR EFFECTIVE TO DIAGNOSE, TREAT, PREVENT, MITIGATE OR CURE ANY CONDITION OR DISEASE.

PRINCIPAL DISPLAY PANEL

Pink Eye
Drops
STERILE EYE DROPS
10 ml (0.33 FL OZ)

INGREDIENTS AND APPEARANCE

PINK EYE REMEDY 
atropa belladonna, calcium sulfide, euphrasia stricta solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53799-403
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_X]  in 10 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X]  in 10 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
WATER (UNII: 059QF0KO0R)
SILVER SULFATE (UNII: 8QG6HV4ZPO)
SODIUM NITRATE (UNII: 8M4L3H2ZVZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53799-403-11	10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	12/01/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/01/2007

Labeler - Similasan AG (481545754)