Label: EQUATE EYE DROPS- tetrahyrozoline hydrochloride liquid
- NDC Code(s): 67172-281-01, 67172-282-01
- Packager: Prestige Brands Holdings, 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 27, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
When using this product
- to avoid contamination, do not touch tip of container to any surface
- replace cap after using
- overuse may produce increased redness of the eye
- pupils may become enlarged temporarily
- to avoid contamination, do not touch tip of container to any surface
- Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
EQUATE EYE DROPS
tetrahyrozoline hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67172-282 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67172-282-01 1 in 1 BOX 02/11/2013 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 02/11/2013 EQUATE EYE DROPS
tetrahyrozoline hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67172-281 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67172-281-01 1 in 1 BOX 02/11/2013 1 30 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 02/11/2013 Labeler - Prestige Brands Holdings, Inc. (159655021)