SPLASH REDNESS RELIEVER- hypromellose, naphazoline hydrochloride solution/ drops 
LABORATORIOS SOPHIA, S.A. DE C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Splash Redness Reliever

Drug Facts

Active ingredient . . . . . . . . . . . . . . . . Purpose
Hypromellose 0.2%............................Lubricant
Naphazoline hydrochloride 0.02%.....Redness reliever

Purpose

Uses

Temporarily relieves

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.

ask a doctor before use if you have narrow angle glaucoma.

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.
  • overuse may cause more redness of the eye
  • pupil may become enlarged temporarily

Keep out of reach of children.

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

Directions

Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.

Other information

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.

Questions?

Call 1-866-282-8871

splashtears.com

Splash ®
Redness Reliever
Lubricant redness reliever Eye drops

Fast-Acting Reliever
0.5 FL OZ (15 mL)


Relieves REDNESS BURNING IRRITATION
Sophia ®


Distributed by:
LABS SOPHIA USA, INC
1790 Hughes Landing Blvd, Suite 400
The Woodlands, TX 77380
MADE IN MEXICO

label

SPLASH REDNESS RELIEVER 
hypromellose, naphazoline hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57619-304
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) (HYPROMELLOSE 2910 (4000 MPA.S) - UNII:RN3152OP35) HYPROMELLOSE 2910 (4000 MPA.S)0.2 g  in 100 mL
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.02 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57619-304-011 in 1 CARTON04/25/2023
115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34904/25/2023
Labeler - LABORATORIOS SOPHIA, S.A. DE C.V. (810143636)
Establishment
NameAddressID/FEIBusiness Operations
LABORATORIOS SOPHIA, S.A. DE C.V.810143636manufacture(57619-304)

Revised: 5/2023
Document Id: fb341385-67f2-c4cb-e053-6294a90aea52
Set id: fa4140e6-dc80-da99-e053-6294a90a194f
Version: 2
Effective Time: 20230508
 
LABORATORIOS SOPHIA, S.A. DE C.V.