PINK EYE NIGHTTIME- belladonna, euphrasia officinalis, hepar sulphuris gel

Pink Eye Nighttime by

Drug Labeling and Warnings

Pink Eye Nighttime 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†

†containing 0.000002% alkaloids calculated as hyoscyamine

Purpose

dryness, redness, burning, sensation of grittiness

Active ingredients

Euphrasia officinalis (Eyebright) 6X

Purpose

watery discharge

Active ingredients

Hepar sulphuris 12X

Purpose

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 1-2 drops into eye

 apply as needed

 replace cap after use

Other information

Active ingredients are manufactured according to homeopathic principles.

Store below 86°F

Inactive ingredients

Borate buffer, Purified water, Silver sulfate (as preservative), Sodium hyaluronate, Sodium nitrate

Questions?

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.
www.SimilasanUSA.com

For your protection do not use if tamper evident seal around neck of bottle is missing or broken.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PRINCIPAL DISPLAY PANEL

Similasan
Pink eye

Nighttime
Gel™
10 mL/ 0.33 fl oz

INGREDIENTS AND APPEARANCE

PINK EYE NIGHTTIME 
belladonna, euphrasia officinalis, hepar sulphuris gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53799-377
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
WATER (UNII: 059QF0KO0R)
SILVER SULFATE (UNII: 8QG6HV4ZPO)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM NITRATE (UNII: 8M4L3H2ZVZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53799-377-11	1 in 1 CARTON	11/09/2020
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		11/09/2020

Labeler - Similasan AG (481545754)