Label: VISINE RED EYE COMFORT- tetrahydrozoline hydrochloride solution/ drops
- NDC Code(s): 69968-0355-1
- Packager: Johnson & Johnson Consumer Inc.
- 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 January 4, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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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 - 15 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
VISINE RED EYE COMFORT
tetrahydrozoline hydrochloride solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0355 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 Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) BORIC ACID (UNII: R57ZHV85D4) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) GLYCERIN (UNII: PDC6A3C0OX) GLYCINE (UNII: TE7660XO1C) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POLIXETONIUM CHLORIDE (UNII: RNW5AM67C0) POTASSIUM CHLORIDE (UNII: 660YQ98I10) WATER (UNII: 059QF0KO0R) SODIUM BORATE (UNII: 91MBZ8H3QO) 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:69968-0355-1 1 in 1 CARTON 04/27/2020 1 15 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 final part349 04/27/2020 Labeler - Johnson & Johnson Consumer Inc. (118772437)