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  5. Label Information: Sodium Chloride Hypertonicity

FDA Label for Sodium Chloride Hypertonicity

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN.
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS OR COMMENTS?
    10. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Sodium Chloride Hypertonicity Product Label

The following document was submitted to the FDA by the labeler of this product Yyba Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Sodium chloride 5%


Purpose



Hypertonicity agent


Uses



temporary relief of corneal edema


Warnings



For external use only

Do not use
except under the advice and supervision of a doctor.

When using this product 

  • it may cause temporary burning and irritation
  • replace cap after use
  • to avoid contamination, do not touch tip of container to any surface

    • Stop use and ask a doctor if

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

Keep Out Of Reach Of Children.



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


Directions



  • pull down the lower lid of the affected eye
  • apply a small amount (1/4 inch) of ointment to the inside of eyelid
  • apply every 3 or 4 hours or as directed by a doctor

Other Information



  • store at 15-25 °C (59-77 °F)
  • keep tightly closed
  • DO NOT FREEZE
  • see crimp of tube or carton for Lot Number and Expiration Date
  • do not use if difficult to dispense or visible particles are seen in the product
  • serious side effects associated with use of the product may be reported to the phone number provided below 

Inactive Ingredients



lanolin, mineral oil, purified water, white petrolatum


Questions Or Comments?



Call 1-866-933-6337


Package/Label Principal Display Panel



carton - image 01

carton - image 01

Welmate TM

NDC 73581-708-35

EYE OINTMENT

sodium chloride hypertonicity

ophthalmic ointment, 5%

5%Temporary Relief
of Corneal Edema

STERILE

NET WT. 1/8 OZ. (3.5 g)

9805700

WM15834


* Please review the disclaimer below.