Manzanilla Sophia: Homeopathic Product Information

MANZANILLA SOPHIA- matricaria recutita solution/ drops
LABORATORIOS SOPHIA, S.A. DE C.V.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Facts

Active ingredient

Chamomile (Matricaria chamomilla L.) 3X HPUS

“HPUS” indicates that this ingredient is officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose

Eye moisturizer

Use* 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 occur
  • redness or irritation of the eye lasts
  • condition worsens or lasts more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Put 2 drops into each eye as needed

Other information

  • store at room temperature.

Do not use

  • if imprinted seal around cap is broken or missing

Inactive ingredients Benzalkonium chloride (as preservative), sodium chloride, sodium phosphate dibasic monohydrate, sodium phosphate monobasic monohydrate, water for injection

Questions?

1-866-202-8871

www.manzanillasophia.com

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

NDC 57619-400-01

Distributed by:

LABS SOPHIA USA, INC.

1790 Hughes Landing Blvd Suite 400

The Woodlands, TX 77380

MADE IN MEXICO

www.sophialabs.com

HOMEOPATHIC

Manzanilla Sophiaâ„¢

Chamomile

Herbal Eye Drops

REFRESH YOUR EYES

Cleanses

Soothes

0.5 FL OZ (15 mL)

STERILE

Manzanilla Sophia 11-2021
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 3 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
WATER
SODIUM CHLORIDE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57619-400-01 1 BOTTLE, PLASTIC in 1 PACKAGE contains a BOTTLE, PLASTIC
1 15 mL in 1 BOTTLE, PLASTIC This package is contained within the PACKAGE (57619-400-01)
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 Operations
LABORATORIOS SOPHIA, S.A. DE C.V. 810143636 manufacture (57619-400)

Revised: 11/2021 LABORATORIOS SOPHIA, S.A. DE C.V.

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