FDA Label for Splash Tears
View Indications, Usage & Precautions
Splash Tears Product Label
The following document was submitted to the FDA by the labeler of this product Laboratorios Sophia, S.a. De C.v.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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, Texas, USA 77060
MADE IN MEXICO
Otc - Active Ingredient
Active ingredient
Hypromellose 0.2%
Otc - Purpose
Purpose
Lubricant eye drops
Indications & Usage
Uses
Temporarily relieves
- burning and irritation due to dryness of the eye.
- discomfort due to minor irritations of the eye or to exposure to wind or sun.
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use if solution changes color or becomes cloudy.
Otc - When Using
When using this product
- do not touch tip of container to any surface to avoid contamination.
- replace cap after using.
Otc - Stop Use
Stop use and ask a doctor if
- you experience eye pain, changes in vision, continued redness or irritation of the eye.
- condition worsens or persists for more than 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
instill 1 or 2 drops in the affected eye(s) as needed
Storage And Handling
Other information
- store at room temperature
- do not use if imprinted seal around cap is broken.
Inactive Ingredient
Inactive ingredients
benzalkonium chloride, boric acid, chondroitin sulfate, decahydrate edetate disodium, magnesium chloride hexahydrate, polysorbate 80, potassium chloride, sodium borate, sodium chloride, water for injection
Otc - Questions
Questions?
Call 1-866-282-8871
www.sophia.com.mx
Package Label.Principal Display Panel
NDC 57619-303-01
Splash TEARS®
Dry Eye Relief
Long Lasting
LUBRICANT EYE DROP
HYPROMELLOSE 0.2%
1/2 FL OZ (15 ML)
STERILE
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