Label: SODIUM CHLORIDE- sodium chloride ointment
- NDC Code(s): 17478-622-35
- Packager: Akorn, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
- Active ingredient
Sodium Chloride 5%Close
for temporary relief of corneal edema.Close
- 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.
Apply small amount (one-fourth inch) to the inside of affected eye(s) every 3 to 4 hours, or as directed by a doctor.Close
- 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.Close
- PRINCIPAL DISPLAY PANEL
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.)Close
- PRINCIPAL DISPLAY PANEL
Principal Display Panel Text for Carton Label:
Comparable to MURO 128®
Net Wt. 3.5 g (1/8oz.)Close
- INGREDIENTS AND APPEARANCE
sodium chloride ointment
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:17478-622 Route of Administration OPHTHALMIC DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Chloride (Sodium Cation and Chloride Ion) Sodium Chloride 50 mg in 1 g Inactive Ingredients Ingredient Name Strength Mineral Oil Lanolin Water Petrolatum Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17478-622-35 1 in 1 CARTON 1 3.5 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 05/08/2006 Labeler - Akorn, Inc. (062649876) Establishment Name Address ID/FEI Business Operations Akorn, Inc 603980319 MANUFACTURE(17478-622), ANALYSIS(17478-622), STERILIZE(17478-622), PACK(17478-622), LABEL(17478-622)