NAPHCON A- naphazoline hydrochloride and pheniramine maleate solution/ drops 
H.J. Harkins Company, Inc.

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0107-03

For external use only

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride, sodium hydroxide and/or hydrochloric acid

for the temporary relief of redness and itching of the eye(s) due to:

Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

label

NAPHCON A 
naphazoline hydrochloride and pheniramine maleate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-107
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.25 mg  in 1 mL
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52959-107-0315 mL in 1 BOTTLE; Type 0: Not a Combination Product01/26/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02022601/26/2016
Labeler - H.J. Harkins Company, Inc. (147681894)
Establishment
NameAddressID/FEIBusiness Operations
H.J. Harkins Company, Inc.147681894relabel(52959-107) , repack(52959-107) , manufacture(52959-107)

Revised: 8/2018
Document Id: 740dff9d-17a9-ffc8-e053-2991aa0ad3a5
Set id: 73fa33b5-606a-d6a8-e053-2991aa0a81c1
Version: 1
Effective Time: 20180821
 
H.J. Harkins Company, Inc.