Label: REFRESH OPTIVE- carboxymethylcellulose sodium and glycerin solution/ drops
- NDC Code(s): 0023-3240-01, 0023-3240-03, 0023-3240-15
- Packager: Allergan, 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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- SPL UNCLASSIFIED SECTION
- Active ingredients
Carboxymethylcellulose sodium 0.5%
- For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
- May be used as a protectant against further irritation.
- For external use only.
- 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.
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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Instill 1 or 2 drops in the affected eye(s) as needed.Close
- Other information
- Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.
- Use before expiration date marked on container.
- Store at 59°-86°F (15°-30°C).
- RETAIN THIS CARTON FOR FUTURE REFERENCE.
- Inactive ingredients
Boric acid; calcium chloride dihydrate; erythritol; levocarnitine; magnesium chloride hexahydrate; potassium chloride; purified water; PURITE® (stabilized oxychloro complex); sodium borate decahydrate; and sodium citrate dihydrate.Close
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
Lubricant Eye Drops
Lubricating and hydrating
formula penetrates the
surface to relieve dryness
0.5 fl oz (15 mL) SterileClose
- INGREDIENTS AND APPEARANCE
carboxymethylcellulose sodium and glycerin solution/ drops
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0023-3240 Route of Administration OPHTHALMIC DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength carboxymethylcellulose sodium (carboxymethylcellulose) carboxymethylcellulose sodium 5 mg in 1 mL glycerin (glycerin) glycerin 9 mg in 1 mL Inactive Ingredients Ingredient Name Strength boric acid calcium chloride erythritol levocarnitine magnesium chloride potassium chloride water sodium chlorite sodium chlorate chlorine dioxide sodium borate trisodium citrate dihydrate Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0023-3240-03 1 in 1 CARTON 1 3 mL in 1 BOTTLE, DROPPER 2 NDC:0023-3240-15 1 in 1 CARTON 2 15 mL in 1 BOTTLE, DROPPER 3 NDC:0023-3240-01 2 in 1 CARTON 3 15 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 09/06/2006 Labeler - Allergan, Inc. (144796497) Establishment Name Address ID/FEI Business Operations Allergan, Inc. 362898611 MANUFACTURE(0023-3240)