Label: ARTIFICIAL TEARS- carboxymethylcellulose sodium solution/ drops
- NDC Code(s): 70403-921-15
- Packager: Aru Pharma 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 May 15, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
• Do not use this product if solution changes color or becomes cloudy
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
When using this product
• to avoid contamination, do not touch tip of container to any surface • replace cap after using. Keep container tightly closed.
• remove contact lens before using
- Directions
- Other information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
-
INGREDIENTS AND APPEARANCE
ARTIFICIAL TEARS
carboxymethylcellulose sodium solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70403-921 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SODIUM CHLORIDE (UNII: 451W47IQ8X) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM CHLORITE (UNII: G538EBV4VF) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70403-921-15 1 in 1 CARTON 01/22/2018 03/31/2025 1 15 mL in 1 BOTTLE, DROPPER; 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 01/22/2018 03/31/2025 Labeler - Aru Pharma Inc. (079736192)