Label: REAL- carboxymethylcellulose sodium solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 59276-403-05, 59276-403-30 - Packager: Oliver Landon Intl 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.
Drug Label Information
Updated December 5, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
- 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
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- Questions or Comments?
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PRINCIPAL DISPLAY PANEL
NDC 59276-403-05
Real
Lubricant Eye Drops- Moisturizing relief
- Immediate, soothing relief for dry eyes.
Preservative-free
Directions
To open, TWIST AND PULL TAB TO REMOVEInstill 1 or 2 drops in the affected eye(s) as needed and discard container.
5 Single-Use Containers
0.01 fl oz (0.4 mL) each Sterile -
INGREDIENTS AND APPEARANCE
REAL
carboxymethylcellulose sodium solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59276-403 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength CALCIUM CHLORIDE (UNII: M4I0D6VV5M) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM LACTATE (UNII: TU7HW0W0QT) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59276-403-05 5 in 1 CARTON 11/14/2018 1 0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 2 NDC:59276-403-30 30 in 1 CARTON 11/14/2018 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 11/14/2018 Labeler - Oliver Landon Intl Inc. (815240195)