KIDS PINK EYE RELIEF- atropa belladonna, calcium sulfide, euphrasia stricta and platycladus orientalis leaf liquid

Kids Pink Eye Relief by

Drug Labeling and Warnings

Kids Pink Eye Relief 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

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 getinfo@similasanusa.com.

www.SimilasanUSA.com

†containing 0.000002% alkaloids calculated as hyoscyamine

PRINCIPAL DISPLAY PANEL

Similasan
Kids
Pink Eye
Relief
STERILE EYE DROPS
10 ml / 0.33 fl oz

INGREDIENTS AND APPEARANCE

KIDS PINK EYE RELIEF 
atropa belladonna, calcium sulfide, euphrasia stricta and platycladus orientalis leaf liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53799-368
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
PLATYCLADUS ORIENTALIS LEAF (UNII: 32E5V7G32B) (PLATYCLADUS ORIENTALIS LEAF - UNII:32E5V7G32B)	PLATYCLADUS ORIENTALIS LEAF	15 [hp_X]  in 10 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53799-368-11	1 in 1 CARTON	11/15/2018
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/15/2018

Labeler - Similasan AG (481545754)