GOODSENSE IRRITATION RELIEF EYE- tetrahydrozoline hci, and zinc sulfate solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077), ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)

Available from:

Geiss, Destin & Dunn, Inc.

Administration route:

OPHTHALMIC

Prescription type:

OTC DRUG

Therapeutic indications:

Uses - for temporary relief of discomfort and redness of the eye due to minor eye irritations Stop use and ask a doctor if - you feel eye pain - changes in vision occur - redness or irritation of the eye lasts - condition worsens or lasts more than 72 hours Directions - to open bottle, push cap down and twist counter-clockwise. To close bottle, twist clockwise until it stops turning. - put 1 to 2 drops in the affected eye(s) up to 4 times daily - children under 6 years of age: ask a doctor

Authorization status:

OTC monograph final

Summary of Product characteristics

GOODSENSE IRRITATION RELIEF EYE- TETRAHYDROZOLINE HCI, AND ZINC
SULFATE SOLUTION/
DROPS
GEISS, DESTIN & DUNN, 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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ACTIVE INGREDIENTS PURPOSE
Tetrahydrozoline HCI 0.05.................Redness reliever
Zinc sulfate 0.25%...........................Astringent
US ES
for temporary relief of discomfort and redness of the eye due to minor
eye irritations
WARNINGS
FOR EXTERNAL USE ONLY
ASK A DOCTOR BEFORE USE IF YOU HAVE
narrow angle glaucoma.
WHEN USING THIS PRODUCT
pupils may become enlarged temporarily
overuse may cause more eye redness
remove contact lenses before using
do not use if this solution changes color or becomes cloudy
do not touch tip of 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 lasts
condition worsens or lasts more than 72 hours
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison Control Center right
away.
DIRECTIONS
to open bottle, push cap down and twist counter-clockwise. To close
bottle, twist clockwise until it
stops turning.
put 1 to 2 drops in the affected eye(s) up to 4 times daily
children under 6 years of age: ask a doctor
OTHER INFORMATION
some users may experience a brief tingling sensation
store at 15° to 25°C (59° to °F)
Inactive ingredients
benzalkonium chloride, boric acid, edetate disodium, purified water,
sodium chloride, sodium citrate
Distributed by:
Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269
www.valuelabels.com
1-866-696-0957
Made in Korea
GOODSENSE IRRITATION RELIEF EYE
tetrahydrozoline hci, and zinc sulfate solution/ drops
Geiss, Destin & Dunn, Inc.
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:5