Refresh Tears Kit
FDA Label NDC 0023-0795

11 label sections · Submitted to the FDA by Allergan, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Allergan, Inc. for the product Refresh Tears (NDC 0023-0795). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Carboxymethylcellulose sodium 0.5%

Purpose

Eye lubricant

Uses

  • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
  • May be used as a protectant against further irritation.

Warnings

  • For external use only.
  • To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • If solution changes color or becomes cloudy, do not use.

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

Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information

  • Use only if tape seals on top and bottom flaps are intact.
  • Use before expiration date marked on container.
  • Discard 90 days after opening.
  • Store at 59°-77°F (15°-25°C).
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive Ingredients

Boric acid; calcium chloride dihydrate; magnesium chloride hexahydrate; potassium chloride; purified water; PURITE® (stabilized oxychloro complex); sodium borate decahydrate; and sodium chloride. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions Or Comments?

1.800.678.1605

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NDC 0023-0798-15
Refresh
TEARS®
Lubricant Eye Drops
Original Strength
Dry Eye Relief

0.5 fl oz (15 mL) Sterile

Ndc 0023-0798-15refreshtears®lubricant Eye Dropsoriginal Strengthdry Eye Relief0.5 Fl Oz (15 mL) Sterile (Refresh Tears 01)

Ndc 0023-0798-15refreshtears®lubricant Eye Dropsoriginal Strengthdry Eye Relief0.5 Fl Oz (15 mL) Sterile (Refresh Tears 01)

NDC 0023-0795-65
5 BOTTLE MULTI-PACK 

Refresh
TEARS®
Lubricant Eye Drops
Original Strength
Lubricates & Moisturizes
4 bottles 0.5 fl oz (15 mL) each
Plus 1 bottle 0.17 fl oz (5 mL) Sterile

Ndc 0023-0795-655 Bottle Multi-pack Refreshtears®lubricant Eye Dropsoriginal Strengthlubricates & Moisturizes4 Bottles 0.5 Fl Oz (15 mL) Eachplus 1 Bottle 0.17 Fl Oz (5 mL) Sterile (Refresh Tears 02)

Ndc 0023-0795-655 Bottle Multi-pack Refreshtears®lubricant Eye Dropsoriginal Strengthlubricates & Moisturizes4 Bottles 0.5 Fl Oz (15 mL) Eachplus 1 Bottle 0.17 Fl Oz (5 mL) Sterile (Refresh Tears 02)

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