Label: ARTIFICAL TEARS- glycerin and propylene glycol solution/ drops
- NDC Code(s): 49035-454-15, 49035-454-30
- Packager: Wal-Mart Stores 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 April 1, 2021
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- Active ingredients
- Purpose
- Uses
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Warnings
For external use only
When using this product
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- do not touch tip of container to any surface to avoid contamination
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- remove contact lenses before using
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- replace cap after use
- Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
ARTIFICAL TEARS
glycerin and propylene glycol solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-454 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 3 mg in 1 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACID (UNII: R57ZHV85D4) EDETATE DISODIUM (UNII: 7FLD91C86K) POTASSIUM CHLORIDE (UNII: 660YQ98I10) WATER (UNII: 059QF0KO0R) SODIUM BORATE (UNII: 91MBZ8H3QO) 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:49035-454-15 1 in 1 CARTON 09/01/2010 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49035-454-30 1 in 1 CARTON 05/31/2017 2 30 mL in 1 BOTTLE; 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 09/01/2010 Labeler - Wal-Mart Stores Inc (051957769) Registrant - Baush & Lomb Incorporated (196603781) Establishment Name Address ID/FEI Business Operations Bausch & Lomb Incorporated 114406598 MANUFACTURE(49035-454)