Label: SEASONAL ITCHY AND RED EYE RELIEF- tetrahydrozoline hcl, zinc sulfate liquid
- NDC Code(s): 67510-0665-1, 67510-0665-5
- Packager: Kareway Product, 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 February 17, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
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Warnings
Ask a doctor before use if you have narrow angle glaucoma.
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 become cloudy
- do not touch tip of container to any surface to avoid contamination
- replace cap after each use
- Directions
- Other information
- Inactive ingredients
- package label
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INGREDIENTS AND APPEARANCE
SEASONAL ITCHY AND RED EYE RELIEF
tetrahydrozoline hcl, zinc sulfate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0665 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE 0.05 mg in 1 mL ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.25 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACID (UNII: R57ZHV85D4) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0665-5 1 in 1 CARTON 11/12/2013 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:67510-0665-1 1 in 1 CARTON 11/12/2013 2 30 mL in 1 BOTTLE; 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 11/12/2013 Labeler - Kareway Product, Inc. (121840057)