EternaTear by Eternatear, Inc. / TUBILUX PHARMA SPA Drug Facts

EternaTear by

Drug Labeling and Warnings

EternaTear by is a Otc medication manufactured, distributed, or labeled by Eternatear, Inc., TUBILUX PHARMA SPA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ETERNATEAR- mineral oil solution 
Eternatear, Inc.

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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Drug Facts

• Active ingredients: Purpose
• Mineral oil (4.5%): Emollient
• Light mineral oil (1%): Emollient

Uses

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

Warnings

For external use only

Do not use

• if solution changes color
• if you are sensitive to any ingredient in this product

When using this product

• do not touch tip of container to any surface to avoid contamination
• replace cap after using

Stop use and ask a doctor if you experience any of the following:

• eye pain
• changes in vision
• continued redness or irritation of the eye
  
• condition worsens or continues 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

• remove contact lenses before use
• shake well before use
• instill 1 or 2 drops in the affected eye(s) as needed
  

Other Information

• store at room temperature

Inactive Ingredients

Beeswax esters (natural), disodium phosphate heptahydrate, hyaluronic acid, monosodium phosphate monohydrate, phosphatidyl glycerol, polysorbate 80, purified water, sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

call 1-919-241-3200

PRINCIPAL DISPLAY PANEL

PRESERVATIVE FREE

EternaTear™
LUBRICATING EYE DROPS

LONGEST LASTING
DRY EYE DROPS*

Unique formula contains
natural beeswax esters

Rebuilds and maintains the tear film

Lasts 4x longer
than other artificial tears

STERILE           0.25 FL OZ (7.5 mL)

PRESERVATIVE FREE

Convenient,
Multi-Use Bottle

ACTUAL SIZE

TAMPER EVIDENT: When using the
product for the first time, make sure
that the sealed ring on the cap has not
been broken. You should feel a slight
resistance until this tamper-proof ring
breaks off.

PRESERVATIVE FREE

PATENTED
CERILAST™
TECHNOLOGY 

Pure beeswax esters
suspended in an
emulsion help lipids
retain and rebuild the
natural tear film.

Fortifies the natural tear film

Increases lipid layer thickness 50%

4+ hour duration on the eye

*Compared to leading artificial tears

NDC: 81913-001-01

Distributed by: EternaTear, Inc.
Raleigh, NC 27609 USA 919-241-3200
Patent pending

EternaTear™ is a trademark of
EternaTear, Inc. All right reserved
Made in Italy from foreign and domestic materials.

ETERNATEAR 
mineral oil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81913-001
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP)	Mineral Oil	150 mg  in 1 mL
Light Mineral Oil (UNII: N6K5787QVP) (Light Mineral Oil - UNII:N6K5787QVP)	Light Mineral Oil	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Yellow Wax (UNII: 2ZA36H0S2V)
Sodium Phosphate, Dibasic, Heptahydrate (UNII: 70WT22SF4B)
Hyaluronic Acid (UNII: S270N0TRQY)
Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Water (UNII: 059QF0KO0R)
Sodium Chloride (UNII: 451W47IQ8X)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81913-001-01	1 in 1 CARTON	08/26/2021	08/27/2021
1		7.5 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	08/26/2021	08/27/2021

Labeler - Eternatear, Inc. (118029357)

Establishment
Name	Address	ID/FEI	Business Operations
TUBILUX PHARMA SPA		338981251	manufacture(81913-001)

Revised: 8/2021

Document Id: 9f04d995-9ad0-4d6b-9337-029e178c62a7

34390-5

Set id: ff10cb43-11e8-4e31-aea7-5c5ae1cd9639

Version: 2

Effective Time: 20210826