OceanTears by Ocean Tears LLC

OceanTears by

Drug Labeling and Warnings

OceanTears by is a Otc medication manufactured, distributed, or labeled by Ocean Tears LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OCEANTEARS- oceantears solution/ drops 
Ocean Tears LLC

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.

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Active Ingredient

Glycerin 0.5%

Purpose

Eye lubricant

Uses

• For the temporary relief of burning and irritation due to dryness of the eye.
• For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
• For use as a protectant against further irritation or to relieve dryness of the eye.

Warnings

EXTERNAL USE ONLY

• To avoid contamination, do not touch tip the bottle closure to any surface(s) including the eye or the skin.
• Do not use if solution changes color or becomes cloudy.

Stop and ask a doctor if

• You experience eye pain, changes in vision, continued redness, or irritation of the eye.
• 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 immediately.

Directions for Use

Instill 1 to 4 drops, 1 to 4 times per day in each eye, or as recommended by your eye care professional.

Inactive Ingredients

Sterile Water, AmnioP™, Sodium Chloride

Other Information

Store at refrigerated conditions once the bottle closure is activated to the open position.

Questions?

OceanTears™ is a fictitious product imagined by a non-profit patient advocacy organization in order to raise awareness about eye drop safety.

For more information please visit eyedropsafety.org or call 800-484-0244.

OCEANTEARS 
oceantears solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83437-001
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	1 mL  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	9 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83437-001-10	1 in 1 BOX	05/05/2023
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M018	05/05/2023	05/04/2024

Labeler - Ocean Tears LLC (118989098)

Revised: 5/2023

Document Id: fcf2c66c-e6a3-cee1-e053-6394a90a5a3a

34390-5

Set id: fa6b071e-c868-9975-e053-6394a90a547f

Version: 2

Effective Time: 20230530