MANZANILLA SOPHIA (chamomile- matricaria chamomilla l. solution/ drops

Manzanilla by

Drug Labeling and Warnings

Manzanilla by is a Homeopathic medication manufactured, distributed, or labeled by LABORATORIOS SOPHIA, S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Homeopathic ingredient

Chamomile (Matricaria chamomilla L.) HPUS 3X

PURPOSE

Use

Use the solution to refresh and replenish moisture to eyes

Warnings

For external use only.

Do not use

if solution changes color or becomes cloudy

When using this product

• Do not touch tip of container to any surface to avoid contamination.
• Replace cap after using.
  

Stop use and ask a doctor if

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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Put 2 drops to each eye as needed.

Other Information

Active ingredient is microdiluted in accordance with the Homeopathic Pharmacopoeia of the United States (HPUS).
Store at room temperature.

Inactive Ingredients

Benzalkonium chloride (as preservative), sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous, purified water, sodium chloride.

Questions?

SPL UNCLASSIFIED SECTION

Excellence in ophthalmics

Manufactured by:

LABORATORIOS SOPHIA, S.A. DE C.V.

Av. Paseo del Norte No. 5255,

Guadalajara, Technology Park

Zapopan, Jalisco, Mexico. C.P. 45010

Distributed by:

LABS SOPHIA USA, INC.

12941 North Freeway Houston, Suite 225

Houston, TX USA 77060

Principal Display Panel

NDC: 57619-400-01

Manzanilla

Sophia

Chamomile (Matricaria Chamomilla L.)

Herbal Eye Drops

Homeopathic

Refresh Your Eyes

0.5 FL OZ (15 mL) sterile

INGREDIENTS AND APPEARANCE

MANZANILLA  SOPHIA
chamomile (matricaria chamomilla l.) solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57619-400
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: 57619-400-01	1 in 1 PACKAGE	04/12/2010
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		04/12/2010

Labeler - LABORATORIOS SOPHIA, S.A. DE C.V. (810143636)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATORIOS SOPHIA, S.A. DE C.V.		810143636	manufacture(57619-400)