NDC | 50090-0185-0 |
Set ID | df40c426-ef66-4688-b5b5-c6fc5556e9a8 |
Category | HUMAN OTC DRUG LABEL |
Packager | A-S Medication Solutions |
Generic Name | |
Product Class | |
Product Number | |
Application Number | NDA020226 |
- ACTIVE INGREDIENT
- Uses
- Warnings
- Do not use
- Ask a doctor before use if you have
- When using this product
- Stop use and ask a doctor if
- Keep out of the reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions?
- HOW SUPPLIED
- naphazoline hydrochloride and pheniramine maleate
-
INGREDIENTS AND APPEARANCE
NAPHCON A
naphazoline hydrochloride and pheniramine maleate solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-0185(NDC:0065-0085) Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE 0.25 mg in 1 mL PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength Benzalkonium Chloride (UNII: F5UM2KM3W7) Boric Acid (UNII: R57ZHV85D4) Edetate Disodium (UNII: 7FLD91C86K) Water (UNII: 059QF0KO0R) Sodium Borate (UNII: 91MBZ8H3QO) Sodium Chloride (UNII: 451W47IQ8X) Sodium Hydroxide (UNII: 55X04QC32I) Hydrochloric Acid (UNII: QTT17582CB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-0185-0 1 in 1 CARTON 11/28/2014 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020226 06/08/1994 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-0185)