Your browser does not support JavaScript! SODIUM CHLORIDE OINTMENT [AKORN, INC.]
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SODIUM CHLORIDE ointment
[Akorn, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Drug Facts

Active ingredient

Sodium Chloride 5%

Purpose

Hypertonicity agent

Use

for temporary relief of corneal edema.

Warnings

  • Do not use this product except under the advice and supervision of a doctor.
  • Do not use if bottom ridge of tube cap is exposed
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.
  • May cause temporary burning and irritation upon application into the eye.

Stop use and ask a doctor if

you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply small amount (one-fourth inch) to the inside of affected eye(s) every 3 to 4 hours, or as directed by a doctor.

Other information

  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • Store away from heat.
  • Protect from freezing.
  • Keep tightly closed.
  • See crimp for Control Number and Expiration Date.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Mineral Oil, Modified Lanolin, Purified Water and White Petrolatum.

Principal Display Panel Text for Container Label:

NDC 17478-622-35 Akorn Logo

Sodium Chloride Ophthalmic

Ointment USP, 5%

Hypertonicity Eye Ointment Sterile

FOR OPHTHALMIC USE ONLY. Net Wt. 3.5 g (1/8oz.)

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC 17478-622-35

3.5 g

Sodium

Chloride

Ophthalmic

Ointment

USP, 5%

Hypertonicity

Eye Ointment

Comparable to MURO 128®

Sterile

Net Wt. 3.5 g (1/8oz.)

Principal Display Panel Text for Carton Label
SODIUM CHLORIDE 
sodium chloride ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:17478-622
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Chloride (Sodium Cation and Chloride Ion) Sodium Chloride50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Mineral Oil 
Lanolin 
Water 
Petrolatum 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-622-351 in 1 CARTON
13.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34905/08/2006
Labeler - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc603980319MANUFACTURE(17478-622), ANALYSIS(17478-622), STERILIZE(17478-622), PACK(17478-622), LABEL(17478-622)

Revised: 6/2012
 
Akorn, Inc.

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