ETERNATEAR- mineral oil solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP), Light Mineral Oil (UNII: N6K5787QVP) (Light Mineral Oil - UNII:N6K5787QVP)

Available from:

Eternatear, Inc.

Administration route:

OPHTHALMIC

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

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._
----------
_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 4 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 se