Label: REFRESH TEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops
- NDC Code(s): 67751-130-01
- Packager: Navajo Manufacturing Company Inc.
- This is a repackaged label.
- Source NDC Code(s): 0023-0798
- 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 March 16, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Stop use and ask a doctor
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
REFRESH TEARS LUBRICANT
carboxymethylcellulose sodium solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67751-130(NDC:0023-0798) 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 BORIC ACID (UNII: R57ZHV85D4) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) WATER (UNII: 059QF0KO0R) SODIUM CHLORITE (UNII: G538EBV4VF) 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:67751-130-01 3 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 12/22/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 09/01/2004 Labeler - Navajo Manufacturing Company Inc. (091917799) Establishment Name Address ID/FEI Business Operations Navajo Manufacturing Company Inc. 136941411 relabel(67751-130) , repack(67751-130) Establishment Name Address ID/FEI Business Operations Allergan, Inc. 362898611 manufacture(67751-130)