Label: VISINE RED EYE HYDRATING COMFORT EYE DROPS- tetrahydrozoline hydrochloride and polyethylene glycol 400 solution/ drops
- NDC Code(s): 67751-198-01
- Packager: Navajo Manufacturing Company Inc.
- This is a repackaged label.
- Source NDC Code(s): 69968-0356
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 15, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
For external use only
When using this product
- pupils may become enlarged temporarily
- overuse may cause more eye redness
- remove contact lenses before using
- do not use if this solution changes color or becomes cloudy
- do not touch tip of container to any surface to avoid contamination
- replace cap after each use
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
VISINE RED EYE HYDRATING COMFORT EYE DROPS
tetrahydrozoline hydrochloride and polyethylene glycol 400 solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67751-198(NDC:69968-0356) Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE 0.5 mg in 1 mL POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) BORIC ACID (UNII: R57ZHV85D4) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) GLYCERIN (UNII: PDC6A3C0OX) GLYCINE (UNII: TE7660XO1C) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POLIXETONIUM CHLORIDE (UNII: RNW5AM67C0) POTASSIUM CHLORIDE (UNII: 660YQ98I10) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM LACTATE (UNII: TU7HW0W0QT) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67751-198-01 1 in 1 BLISTER PACK 06/01/2020 1 8 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 06/01/2020 Labeler - Navajo Manufacturing Company Inc. (091917799) Registrant - Navajo Manufacturing Company Inc. (136941411) Establishment Name Address ID/FEI Business Operations Navajo Manufacturing Company Inc. 136941411 relabel(67751-198)