Label: SODIUM CHLORIDE solution/ drops
-
Contains inactivated NDC Code(s)
NDC Code(s): 17238-625-15 - Packager: HUB Pharmaceuticals
- 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 13, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts:
- Inactive Ingredients:
- Preservative:
- Directions:
- Dosage & Administration:
- Indications:
- PURPOSE
-
WARNINGS
External use only
Do Not Use
- this product except under the advice and supervision of a doctor
- if imprinted seal is broken or missing
- if solution changes color or becomes cloudy
When using this product:
- temporoary burning and iritation upon being instilled into eye may occur
- To avoid contamination, do not touch top of container to any surface
- Replace cap after using, keep tightly closed
In case of accidental ingestion, seek professional help or contact a Poision Control Center immediately.
Stop use and ask a doctor if:
- you experience eye pain, changes in vision, continued redness, or irritation of the eye.
- if the condition worses or persists
- USER SAFETY WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- STORAGE AND HANDLING
- Questions?
- REPRESENTATIVE PACKAGING:
-
INGREDIENTS AND APPEARANCE
SODIUM CHLORIDE
sodium chloride solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17238-625 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) BORIC ACID (UNII: R57ZHV85D4) HYPROMELLOSES (UNII: 3NXW29V3WO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BORATE (UNII: 91MBZ8H3QO) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) HYDROCHLORIC ACID (UNII: QTT17582CB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17238-625-15 1 in 1 BOX 10/15/2014 1 15 mL in 1 BOTTLE, PLASTIC; 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 09/12/2013 Labeler - HUB Pharmaceuticals (611747945) Establishment Name Address ID/FEI Business Operations Conta Care Ophthalmics and Diagnostics 915821765 manufacture(17238-625)
