Label: REFRESH CLASSIC- polyvinyl alcohol, povidone solution/ drops
- NDC Code(s): 0023-0506-01, 0023-0506-50
- Packager: Allergan, 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.
Updated April 15, 2011
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- For external use only.
- To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.
- Do not touch unit-dose tip to eye.
- If solution changes color or becomes cloudy, do not use.
Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
polyvinyl alcohol, povidone solution/ drops
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0023-0506 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED 14 mg in 1 mL Povidone (UNII: FZ989GH94E) (Povidone - UNII:FZ989GH94E) Povidone 6 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) sodium chloride (UNII: 451W47IQ8X) hydrochloric acid (UNII: QTT17582CB) sodium hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0023-0506-01 30 in 1 CARTON 09/12/1985 1 0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 2 NDC:0023-0506-50 50 in 1 CARTON 09/12/1985 2 0.4 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 09/12/1985 Labeler - Allergan, Inc. (144796497)