Label: SPLASH TEARS- hypromellose solution/ drops
- NDC Code(s): 57619-303-01, 57619-303-03
- Packager: LABORATORIOS SOPHIA, S.A. DE C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 9, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only.
When using this product
- do not touch tip of container to any surface to avoid contamination.
- replace cap after using.
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SPLASH TEARS
hypromellose solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57619-303 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM BORATE (UNII: 91MBZ8H3QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) POTASSIUM CHLORIDE (UNII: 660YQ98I10) BORIC ACID (UNII: R57ZHV85D4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57619-303-01 1 in 1 CARTON 05/13/2020 1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:57619-303-03 1 in 1 CARTON 07/24/2020 2 2 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M018 05/13/2020 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(57619-303)