Label: ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops
- NDC Code(s): 0536-1970-72
- Packager: Rugby Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
Polyvinyl Alcohol 1.4%Close
- relieves dryness of the eye
- prevents further irritation
- Do not use if solution changes color or becomes cloudy
- with contact lenses
When using this product
- do not touch tip of container to any surface to avoid contamination
- replace cap after use
Stop use and ask a doctor if
- you experience eye pain, changes in vision, continued redness or irritation of the eye
- condition worsens or lasts for more than 72 hours
- Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.Close
- instill 1 to 2 drops in the affected eye(s) as needed.
- Other information
- store at 15° - 30°C (59° - 86°F)
- keep tightly closed
- Inactive ingredients
dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate,
purified water, sodium chloride. Phosphoric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride 0.01%Close
- Questions or comments?
9 am - 5 pm ET, Monday-Friday.
Serious side effects associated with use of this product may be reported to this number
Duluth, GA 30097Close
- Package/Label Principal Display Panel
COMPARED TO ACTIVE INGREDIENTS IN LIQUIFILM® TEARS*
Artificial Tears Solution
Polyvinyl Alcohol 1.4%
Prevents irritation and relieves Dryness of the eye
1/2 fl oz (15 mL)Close
- INGREDIENTS AND APPEARANCE
polyvinyl alcohol solution/ drops
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1970 Route of Administration OPHTHALMIC DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL 14 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1970-72 15 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 10/07/2011 Labeler - Rugby Laboratories Inc. (109178264) Registrant - Bausch & Lomb Incorporated (196603781) Establishment Name Address ID/FEI Business Operations Bausch & Lomb Incorporated 196603781 MANUFACTURE