Walgreens Lubricant Eye Drops Preservative Free: Package Insert and Label Information

WALGREENS LUBRICANT EYE DROPS PRESERVATIVE FREE- light mineral oil and mineral oil emulsion
Walgreen Company

Disclaimer: 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.

Active Ingredients

Light Mineral Oil (0.5)…………………………..Emollient

Mineral Oil (0.5%)……………………………….Emollient

Uses

For use as a protectant against further irritation or to relieve dryness of the eye.

Warnings

For use in the eyes only.

Retain outer carton for full product drug facts.

Do not use

Do not use if:

This product changes color, drops should appear as a milky white solution.

When using this product

• Avoid contamination, do not touch tip of container to any surface.

• Do not reuse once opened

Stop use and ask a doctor if

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

KEEP OUT OF THE REACH OF CHILDREN

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

Directions

  • Shake well before using.
  • Squeeze 1 to 2 drops in the affeted eye(s) as needed.
  • Do not reuse. Once opened discard.

Other Information

  • Store between 15 o -30 o C (59 o -86 o F).
  • Store away from heat
  • Keep from freezing
  • Use only if tamper evident seals on the carton are intact and the twist top of single use container is intact.

Inactive ingredients

Cetalkonium chloride, glycerol, poloxamer 188, tris hydrochloride, tromethamine, tyloxapol, water for injection.

Questions or comments?

Questions or comments?

• 1-800-925-4733

• 9am– 5pm EST

Monday — Friday

Emollient

If pregnant or breast feeding

If pregnant or breast feeding, ask a health professional before use

PRINCIPAL DISPLAY PANEL — 30 sterile Single-Dose Containers Carton

Carton
(click image for full-size original)

WALGREENS LUBRICANT EYE DROPS PRESERVATIVE FREE
mineral oil emulsion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-8831
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIGHT MINERAL OIL (LIGHT MINERAL OIL) LIGHT MINERAL OIL 2 mg in 0.4 mL
MINERAL OIL (MINERAL OIL) MINERAL OIL 2 mg in 0.4 mL
Inactive Ingredients
Ingredient Name Strength
CETALKONIUM CHLORIDE
GLYCERIN
POLOXAMER 188
TROMETHAMINE HYDROCHLORIDE
TROMETHAMINE
TYLOXAPOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-8831-22 30 VIAL, SINGLE-DOSE in 1 CONTAINER contains a VIAL, SINGLE-DOSE
1 0.4 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CONTAINER (0363-8831-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 04/11/2020
Labeler — Walgreen Company (008965063)

Revised: 09/2021 Walgreen Company

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