Label: VISINE A.C. ITCHY EYE RELIEF- tetrahydrozoline hydrochloride and zinc sulfate, unspecified form solution/ drops
- NDC Code(s): 69968-0366-1
- 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 3, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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
- some users may experience a brief tingling sensation
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
VISINE A.C. ITCHY EYE RELIEF
tetrahydrozoline hydrochloride and zinc sulfate, unspecified form solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0366 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 ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE, UNSPECIFIED FORM 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACID (UNII: R57ZHV85D4) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0366-1 1 in 1 CARTON 05/06/2019 1 15 mL in 1 BOTTLE; 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 final part349 05/06/2019 Labeler - Johnson & Johnson Consumer Inc. (118772437)