Label: SPLASH REDNESS RELIEVER- hypromellose, naphazoline hydrochloride solution/ drops
- NDC Code(s): 57619-304-01
- Packager: LABORATORIOS SOPHIA, S.A. DE C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 8, 2023
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- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- Uses
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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.
- Directions
- Other information
- Inactive ingredients
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPLASH REDNESS RELIEVER
hypromellose, naphazoline hydrochloride solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57619-304 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 NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE 0.02 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:57619-304-01 1 in 1 CARTON 04/25/2023 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 OTC monograph final part349 04/25/2023 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(57619-304)