OTC Medication Information: Sunmark Lubricant Eye Drops

SUNMARK LUBRICANT EYE DROPS- polyethylene glycol 400 and propylene glycol solution/ drops
Strategic Sourcing Services LLC

Active Ingredients

Polyethylene glycol 400 0.4%, Propylene glycol 0.3%

Purpose

Lubricant

Uses

for the temporary relief of burning and irritation due to dryness of the eye

Warnings

For external use only

Do not use

  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product

When using this product

  • do not touch the tip of the container to any surface to avoid contamination
  • replace cap after each use

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse or lasts 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
  • children under 6 years of age: ask a doctor

Other information

  • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • Store at room temperature

Inactive ingredients

Benzalkonium chloride as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, zinc chloride

Carton
(click image for full-size original)

SUNMARK LUBRICANT EYE DROPS
polypropylene glycol 400, propylene glycol solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-947
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 400 (POLYETHYLENE GLYCOL 400) POLYETHYLENE GLYCOL 400 0.4 g in 100 mL
PROPYLENE GLYCOL (PROPYLENE GLYCOL) PROPYLENE GLYCOL 0.3 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
BORIC ACID
CALCIUM CHLORIDE
HYPROMELLOSES
MAGNESIUM CHLORIDE
POTASSIUM CHLORIDE
WATER
SODIUM BORATE
SODIUM CHLORIDE
ZINC CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49348-947-29 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 15 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (49348-947-29)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M018 12/01/2010
Labeler — Strategic Sourcing Services LLC (116956644)
Registrant — KC Pharmaceuticals, Inc (174450460)
Establishment
Name Address ID/FEI Operations
KC Pharmaceuticals, Inc. 174450460 manufacture (49348-947), pack (49348-947), label (49348-947)

Revised: 12/2023 Strategic Sourcing Services LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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