Label: EQUATE COMFORT- carboxymethylcellulose sodium and hypromelloses gel
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Contains inactivated NDC Code(s)
NDC Code(s): 49035-197-49 - 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 January 19, 2018
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
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Warnings
For use in the eyes only.
● Retain outer carton for full product drug facts.
When using this product
● avoid contamination, do not touch tip of container to any surface.
● replace cap after each use.
- Directions
- Other Information
- Inactive Ingredients:
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EQUATE COMFORT
carboxymethylcellulose sodium and hypromelloses gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-197 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES 3 mg in 1 mL CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) WATER (UNII: 059QF0KO0R) SODIUM BORATE (UNII: 91MBZ8H3QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) CHLORINE DIOXIDE (UNII: 8061YMS4RM) POLIHEXANIDE (UNII: 322U039GMF) Other Ingredients Ingredient Kind Ingredient Name Quantity May contain HYDROCHLORIC ACID (UNII: QTT17582CB) May contain SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-197-49 2 in 1 CARTON 04/10/2014 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 04/10/2014 Labeler - Wal-Mart Stores, Inc. (051957769) Registrant - Altaire Pharmaceuticals, Inc. (786790378)