Label: CAREONE ITCHY RELIEF EYE DROPS 15ML- tetrahydrozoline hci, zinc sulfate liquid
- NDC Code(s): 72476-011-01
- Packager: Retail Business Services, LLC.
- 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 December 12, 2019
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purposes
- Uses
-
Warnings
For external use only
When using this product
- pupils may become enlarged temporarily
- to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
- if solution changes color or becomes cloudy, do not use
- overuse may produce increased redness of the eye
- remove contact lenses before using
- Directions
- Other information
- Inactive ingredients
- Careone Itchy Relief Eye Drops 15mL
-
INGREDIENTS AND APPEARANCE
CAREONE ITCHY RELIEF EYE DROPS 15ML
tetrahydrozoline hci, zinc sulfate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72476-011 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE 0.25 g in 100 mL TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE 0.05 g in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM CHLORIDE (UNII: 451W47IQ8X) BORIC ACID (UNII: R57ZHV85D4) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72476-011-01 1 in 1 BOX 10/29/2019 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 10/29/2019 Labeler - Retail Business Services, LLC. (967989935) Registrant - KC Pharmaceuticals, Inc. (174450460) Establishment Name Address ID/FEI Business Operations KC Pharmaceuticals, Inc. 174450460 manufacture(72476-011) , pack(72476-011) , label(72476-011)