Mermaid Tears by Ocean Tears LLC

Mermaid Tears by

Drug Labeling and Warnings

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

Drug Details [pdf]

MERMAID TEARS- mermaid tears solution 
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 0.4%

Purpose

• Eye lubricant.

Uses

• To protect against eye irritation from salt water.
• To allow you to see like a mermaid under water.

Warnings

• This is a non-preserved eye drop improperly packaged in a standard eye drop bottle. Do not, if you love your corneas, allow the dropper tip to touch anything (even air).
• Do not use if solution changes color, becomes cloudy, or shows evidence of spontaneous carbonation.

Precautions During Use

• Objects under water are closer than they appear.
• This means sharks.

Directions for Use

• Apply 2 drops to each eye 30 minutes before entering the ocean.
• Apply 1 drop as needed to maintain clear underwater vision, but not more often than once per hour.
• Do not apply more than 6 total drops in a 24 hour period.

Inactive Ingredients

BOPE™, sodium chloride, sterile water

Stop Use If

Your pupils change shape from round to vertical or horizontal slits.

Keep out of reach of children.

• If swallowed, get medical help, ideally at an aquarium.
• If no aquariums are nearby, look for a store that sells saltwater fish as pets, not as food.
• As a last resort, contact a Poison Control Center. Advise them that the active Inactive Ingredient is BOPE™, which is proprietary, may affect your genome, and is not in their database.

Storage

• Keep frozen until use.
• After thawing, store at room temperature up to 3 years.

Questions?

Mermaid Tears™ 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.

Box art.

MERMAID TEARS 
mermaid tears solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83437-002
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	4 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: 83437-002-10	1 in 1 BOX	05/06/2023	05/06/2024
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	05/06/2023	05/06/2024

Labeler - Ocean Tears LLC (118989098)

Revised: 6/2023

Document Id: fd1c0aef-70dc-9c8f-e053-6394a90aa150

34390-5

Set id: fb0b58ea-565b-9aae-e053-6394a90acbbf

Version: 2

Effective Time: 20230601