Label: FIRST AID DIRECT BUFFERED EYEWASH STERILE ISOTONIC- water solution
-
Contains inactivated NDC Code(s)
NDC Code(s): 42961-300-20 - Packager: Cintas Corporation
- 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 11, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
-
Warnings
- to avoid contamination, do not touch tip of container to any surface, Do not reuse. Once opened, discard.
- obtain immediate medical treatment for all open wounds in or near the eyes
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 1 fl oz Bottle Label
-
INGREDIENTS AND APPEARANCE
FIRST AID DIRECT BUFFERED EYEWASH STERILE ISOTONIC
water solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-300 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R) Water 0.98 mL in 1 mL Inactive Ingredients Ingredient Name Strength Benzalkonium chloride (UNII: F5UM2KM3W7) Edetate disodium (UNII: 7FLD91C86K) Sodium chloride (UNII: 451W47IQ8X) Sodium phosphate, Dibasic, Heptahydrate (UNII: 70WT22SF4B) Sodium phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-300-20 4 in 1 BOX, UNIT-DOSE 10/01/2011 1 30 mL in 1 BOTTLE, UNIT-DOSE; 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 10/01/2011 Labeler - Cintas Corporation (056481716) Registrant - Cintas Corporation (056481716) Establishment Name Address ID/FEI Business Operations Horizon Pharmaceuticals, Inc. 960418825 MANUFACTURE(42961-300) , STERILIZE(42961-300) , LABEL(42961-300) , PACK(42961-300) , ANALYSIS(42961-300)