Dry Eye Relief (Atropa Belladonna And Euphrasia Stricta And Mercuric Chloride) Solution/ Drops [Similasan Corporation] -

DRY EYE RELIEF (ATROPA BELLADONNA AND EUPHRASIA STRICTA AND MERCURIC CHLORIDE) SOLUTION/ DROPS [SIMILASAN CORPORATION]
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NDC	59262-352-01, 59262-352-13
Set ID	556395b6-a928-44a0-929a-e7ffa2f5e358
Category	HUMAN OTC DRUG LABEL
Packager	Similasan Corporation
Generic Name
Product Class
Product Number
Application Number

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Active Ingredient

Belladonna* 6X

*containing 0.000002% alkaloids calculated as hyoscyamine.
Purpose

dryness, redness
Active Ingredient

Euphrasia 6X
Purpose

redness
Active Ingredient

Mercurius sublimatus 6X
Purpose

dryness
Uses
According to homeopathic principles, the active ingredients in this medication temporarily relieve minor symptoms such as:
- dry eye
- redness of eyes and lids
- reflex watering secondary to dry eye
- sensation of grittiness
- sensitivity to light
Warnings
- For external use only.
- Initial exacerbation of symptoms may occur.
- 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 wearers: consult a physician prior to using.
Do not use:

if the solution changes color or becomes cloudy
Stop use and ask a doctor if:
- symptoms worsen or persist for more than 72 hours.
- changes in vision occur.
- you experience eye pain.
If 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.
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
Inactive Ingredients

Phosphate buffer, Purified water
Principal Display Panel

NDC 59262-352-13
Similasan
Dry Eye
Relief
SINGLE-USE STERILE EYE DROPS
Preservative Free
0.4 ml/ 0.014 fl oz each
Principal Display Panel

SIMILASAN / USA
30011
Dry Eye Relief, eye drops
270 pieces(Stk)

INGREDIENTS AND APPEARANCE

DRY EYE RELIEF
atropa belladonna and euphrasia stricta and mercuric chloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59262-352
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_X] in 0.4 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X] in 0.4 mL
MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42)	MERCURIC CHLORIDE	6 [hp_X] in 0.4 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:59262-352-01	270 in 1 CARTON	07/02/2013
1		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2	NDC:59262-352-13	.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product	07/02/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED HOMEOPATHIC		07/02/2013

Labeler - Similasan Corporation (111566530)

Name	Address	ID/FEI	Business Operations
Establishment
International Packaging Inc		071493142	REPACK(59262-352)

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Medic

DRY EYE RELIEF (ATROPA BELLADONNA AND EUPHRASIA STRICTA AND MERCURIC CHLORIDE) SOLUTION/ DROPS [SIMILASAN CORPORATION]

Do not use:

Stop use and ask a doctor if:

If pregnant or breast feeding,

Keep out of reach of children

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