Label: VISINE ORIGINAL REDNESS RELIEF- tetrahydrozoline hydrochloride solution/ drops
- NDC Code(s): 42002-203-02, 42002-203-35
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
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 September 22, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- 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 ORIGINAL REDNESS RELIEF
tetrahydrozoline hydrochloride solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42002-203 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 Benzalkonium Chloride (UNII: F5UM2KM3W7) Boric Acid (UNII: R57ZHV85D4) Edetate Disodium (UNII: 7FLD91C86K) Water (UNII: 059QF0KO0R) Sodium Borate (UNII: 91MBZ8H3QO) Sodium Chloride (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42002-203-02 1 in 1 CARTON 10/01/2009 09/30/2022 1 15 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 2 NDC:42002-203-35 1 in 1 CARTON 10/01/2009 08/31/2016 2 19 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 FINAL part349 10/01/2009 09/30/2022 Labeler - Johnson & Johnson Consumer Inc. (002347102)