Manzanilla Sophia

Manufacturer: Teresa Cecena DBA Genesis | Teresa Cecena | Laboratorios Sophia S.A. De C.V.
Effective date: 2015-05-26
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:31:51

Label at a glance#

ProductManzanilla Sophia

Active ingredientMATRICARIA RECUTITA

Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

HOMEOPATHIC INGREDIENT

Chamomile ( Matricaria chamomilla L.) HPUS 3X

OTC - PURPOSE SECTION

USE

Use the solution to refresh and replenish moisture to eyes

WARNINGS SECTION

WARNINGS

FOR EXTERNAL USE ONLY

OTC - DO NOT USE SECTION

DO NOT USE

If solution changes color or become cloudy

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manzanilla

DOSAGE & ADMINISTRATION SECTION

Put 2 drops to each eye as needed

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69772-500-01	2021-11-15	C162847	48780-1	9d75b9d0-1a35-f424-e053-dadaa90a57ce	1703aab5-f83a-0d3b-e054-00144ff8d46c
69772-500-01	2020-01-31	C162847	48780-1	9d75b9d0-1a35-f424-e053-dadaa90a57ce	1703aab5-f83a-0d3b-e054-00144ff8d46c

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MATRICARIA RECUTITA	ACTIVE INGREDIENT	G0R4UBI2ZZ	1
MATRICARIA RECUTITA	ACTIVE MOIETY	G0R4UBI2ZZ	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	1
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

Manzanilla Sophia
Matricaria recutita
BENZALKONIUM CHLORIDE
WATER
SODIUM CHLORIDE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC ANHYDROUS

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69772-500	69772-500-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MATRICARIA RECUTITA	G0R4UBI2ZZ	ACTIB
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
WATER	059QF0KO0R	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	IACT
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	22ADO53M6F	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 242 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SUSPENSION / OPHTHALMIC	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	TABLET, DELAYED RELEASE / ORAL	35 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SUSPENSION / ORAL		104 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVENOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SOLUTION / INTRAVESICAL	0.12 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, SUSPENSION / INTRA-ARTICULAR		13 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / IONTOPHORESIS	0.6 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	CAPSULE, DELAYED RELEASE / ORAL		43 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SOLUTION / SUBCUTANEOUS	0.11 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, DELAYED RELEASE / ORAL		97 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / OPHTHALMIC	0.08 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / VAGINAL	10 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRABURSAL	9 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION/ DROPS / OPHTHALMIC	1.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / NASAL	40.46 mg/100ml		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL	1.35 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION / OPHTHALMIC	1.21 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / NASAL	7.4 mg/1ml		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, EXTENDED RELEASE / ORAL	335.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION / INTRALESIONAL		14 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION / INTRAVITREAL	0.86 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SUSPENSION / INTRAMUSCULAR		36 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVITREAL	10 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACARDIAC		70 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / TOPICAL	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET / ORAL		231 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION / INTRAMUSCULAR		120 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAMUSCULAR		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRALESIONAL		13 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	LOTION / TOPICAL		8 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / ORAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRALESIONAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INFILTRATION		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION / INTRA-ARTICULAR		14 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	TABLET, FILM COATED / ORAL	0.01 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RESPIRATORY (INHALATION)		108 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		2922 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SOLUTION / TOPICAL	0.46 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, EMULSION / INTRAVENOUS	0.28 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SUSPENSION / INTRASYNOVIAL		3 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		30 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	0.68 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, SUSPENSION / INTRALESIONAL		13 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL		11 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / OPHTHALMIC	2 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SOLUTION / INTRATHECAL		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d07056de-18a2-302b-e053-2a95a90ab62b			1703aab5-f83a-0d3b-e054-00144ff8d46c	2021-11-10	Warnings	Exact identifier spl set id: 1703aab5-f83a-0d3b-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.