Label: ROHTO PRESERVATIVE FREE DRY AID- povidone, propylene glycol liquid
- NDC Code(s): 10742-8161-1
- Packager: The Mentholatum Company
- 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 April 14, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
When using this product
- do not touch tip of container to any surface to avoid contamination
- do not reuse
- once opened, discard
- do not use if solution changes color or becomes cloudy
- Directions
- Inactive ingredients
- Questions?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
ROHTO PRESERVATIVE FREE DRY AID
povidone, propylene glycol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-8161 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E) POVIDONE, UNSPECIFIED 6.8 mg in 1 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) EDETATE DISODIUM (UNII: 7FLD91C86K) MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I) RACEMENTHOL (UNII: YS08XHA860) POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O) PEG/PPG-105/5 COPOLYMER (UNII: 52901V8XAR) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) WATER (UNII: 059QF0KO0R) SESAME OIL (UNII: QX10HYY4QV) SODIUM BORATE (UNII: 91MBZ8H3QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-8161-1 30 in 1 CARTON 06/03/2022 1 0.5 mL in 1 VIAL, SINGLE-USE; 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 06/03/2022 Labeler - The Mentholatum Company (002105757)