Label: BASIC CARE EYE- tetrahydrozoline hcl, zinc sulfate solution/ drops
- NDC Code(s): 72288-112-05
- Packager: Amazon.com Services LLC
- 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 July 22, 2021
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- Active ingredients
- Purposes
- Use
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Warnings
For external use only
When using this product
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- pupils may become enlarged temporarily
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- overuse of this product may produce increased redness of the eye
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- remove contact lenses before using
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- if solution changes color or becomes cloudy, do not use
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- do not touch tip of container to any surface to avoid contamination
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- replace cap after each use
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
BASIC CARE EYE
tetrahydrozoline hcl, zinc sulfate solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72288-112 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE .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:72288-112-05 1 in 1 CARTON 07/22/2021 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 07/22/2021 Labeler - Amazon.com Services LLC (128990418)