MANZANILLA SOPHIA- matricaria recutita liquid

Manzanilla Sophia by

Drug Labeling and Warnings

Manzanilla Sophia by is a Homeopathic medication manufactured, distributed, or labeled by Teresa Cecena DBA Genesis, Teresa Cecena, Laboratorios Sophia S.A. De C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

HOMEOPATHIC INGREDIENT

Chamomile ( Matricaria chamomilla L.) HPUS 3X

PURPOSE

USE

Use the solution to refresh and replenish moisture to eyes

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE

DO NOT USE

If solution changes color or become cloudy

WHEN USING

WHEN USING THIS PRODUCT

• Do not touch tip pf container to any surface to avoid contamination
• Remplace cap after using.

STOP USE

STOP USE AND ASK A DOCTOR IF

• You feel eye pain
• Change in vision
• Continued redness or irritation of the eye
• The condition worsens or persists

KEEP OUT OF REACH OF CHILDREN

KEEP THIS AN D ALL DRUGS OUT OF REACH OF CHILDREN, IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

INDICATIONS & USAGE

DIRECTIONS

Put 2 drops to each eye as needed

OTHER SAFETY INFORMATION

OTHER INFORMATION

Active ingredient is microdiluted in accordance with the Homeopathic Pharmacopoeia of United States (HPUS)

Store at room temperature

INACTIVE INGREDIENT

Benzalkonium chloride ( As perservative), sodium phosphaye monobasic monohydrate, sodium phosphate dibasic anhydrous, purified water, sodium chloride.

PRINCIPAL DISPLAY PANEL

DOSAGE & ADMINISTRATION

Put 2 drops to each eye as needed

INGREDIENTS AND APPEARANCE

MANZANILLA SOPHIA 
matricaria recutita liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69772-500
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	3 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69772-500-01	1 in 1 JUG	05/27/2015
1		15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/27/2015

Labeler - Teresa Cecena DBA Genesis (078760958)

Registrant - Teresa Cecena (078760958)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratorios Sophia S.A. De C.V.		810143636	manufacture(69772-500)