Label: ROHTO DIGI-EYE- hypromellose, tetrahydrozoline hydrochloride liquid
- NDC Code(s): 10742-8175-1
- Packager: The Mentholatum Company
- 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 8, 2023
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
- Purpose
- Uses
-
Warnings
For external use only
When using this product
- do not touch tip of container to any surface to avoid contamination
- replace cap after each use
- do not use if solution changes color or becomes cloudy
- overuse may cause more eye redness
- pupils may become enlarged temporarily
- remove contact lenses before using
- Directions
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
ROHTO DIGI-EYE
hypromellose, tetrahydrozoline hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-8175 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO) HYPROMELLOSE, UNSPECIFIED 3.5 mg in 1 mL 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) CHLOROBUTANOL (UNII: HM4YQM8WRC) CYANOCOBALAMIN (UNII: P6YC3EG204) EDETATE DISODIUM (UNII: 7FLD91C86K) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM ASPARTATE (UNII: OC4598NZEQ) WATER (UNII: 059QF0KO0R) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) SODIUM BORATE (UNII: 91MBZ8H3QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-8175-1 1 in 1 CARTON 03/01/2018 1 13 mL in 1 BOTTLE, WITH APPLICATOR; 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 03/01/2018 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations Rohto-Mentholatum (Vietnam) Co. Ltd. 555347535 manufacture(10742-8175)