Welmate Tm

Welmate Tm
SPL v3
SPL
SPL Set ID 439653b9-99b8-4799-8d67-4a2ada9c6783
Route
OPHTHALMIC
Published
Effective Date 2024-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (50 mg)
Inactive Ingredients
Lanolin Water Petrolatum Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-12

Description

Sodium chloride 5%

Purpose

Hypertonicity agent


Medication Information

Purpose

Hypertonicity agent

Description

Sodium chloride 5%

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
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
Active Ingredient

Sodium chloride 5%

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

Keep Out of Reach of Children.

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

Package/label Principal Display Panel

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


Structured Label Content

Uses

temporary relief of corneal edema

Purpose

Hypertonicity agent

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
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
Active Ingredient (Active ingredient)

Sodium chloride 5%

Other Information (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 (Inactive ingredients)

lanolin, mineral oil, purified water, white petrolatum

Questions Or Comments? (Questions or comments?)

Call 1-866-933-6337

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

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


Advanced Ingredient Data


Raw Label Data

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