SODIUM CHLORIDE- sodium chloride solution/ drops 
HUB Pharmaceuticals

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.

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Sodium Chloride 5% Solution USP (Sterile)

Drug Facts:

Active Ingredient

(each mL contains)

Purpose

Sodium Chloride USP

5% w/v (50mg)

Hypertonicity agent

Inactive Ingredients:

Boric Acid, Hypromellose, Propylene Glycol, Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH, and Water for Injection.

Preservative:

Methylparaben

USP 0.023% w/v

PropylparabenUSP 0.01% w/v

Directions:

Dosage & Administration:

Instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours as needed or directed by a doctor.

Indications:

For the temporaty relief of corneal edema.

For the temporaty relief of corneal edema.

External use only

Do Not Use

When using this product:

In case of accidental ingestion, seek professional help or contact a Poision Control Center immediately.

Stop use and ask a doctor if:

save box for complete warnings and instructions

Keep out of reach of children

If swallowed, get medical help for contact a Poison Control Center immediately.

Store at room temperature 15°-30°C (59°-86°F).

Questions?

1-800-Eye-Drop (393-3767)

Monday to Friday 8 AM - 4 PM PST

REPRESENTATIVE PACKAGING:

HUB_NaCl Box

Sodium Chloride Solution Label

HUB_NaCl Label

Sodium Chloride Solution Box

SODIUM CHLORIDE 
sodium chloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17238-625
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17238-625-151 in 1 BOX10/15/2014
115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/12/2013
Labeler - HUB Pharmaceuticals (611747945)
Establishment
NameAddressID/FEIBusiness Operations
Conta Care Ophthalmics and Diagnostics915821765manufacture(17238-625)

Revised: 12/2017
Document Id: 6040b4ad-a872-004e-e053-2a91aa0ae787
Set id: cd8cb7a8-084d-4a1b-9302-911f7a6330c8
Version: 6
Effective Time: 20171213
 
HUB Pharmaceuticals