NDC | 68276-005-01, 68276-005-02, 68276-005-03, 68276-005-04, 68276-005-05 |
Set ID | e5ed271a-46e7-479a-b603-3e5c6f38815f |
Category | HUMAN OTC DRUG LABEL |
Packager | Aaxis Pacific |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART349 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings: For external use only. To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard, do not transfer to other bottle containers. If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists, consult a doctor, obtain immediate medical treatment for all open wounds in or near the eyes. If solution changes color or becomes cloudy, do not use.
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SALINAAX EYE WASH AND SKIN FLUSH
water rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68276-005 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R) Water 98.6 mL in 100 mL Inactive Ingredients Ingredient Name Strength Potassium phosphate, monobasic (UNII: 4J9FJ0HL51) Sodium chloride (UNII: 451W47IQ8X) Sodium hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68276-005-01 148 mL in 1 BOTTLE 2 NDC:68276-005-02 236 mL in 1 BOTTLE 3 NDC:68276-005-03 472 mL in 1 BOTTLE 4 NDC:68276-005-04 944 mL in 1 BOTTLE 5 NDC:68276-005-05 15 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 03/11/2011 Labeler - Aaxis Pacific (751370305) Establishment Name Address ID/FEI Business Operations Opto Pharm Pte Ltd 595239682 manufacture