CAREONE EYE DROPS SEASONAL RELIEF- tetrahydrozoline hcl and zinc sulfate solution/ drops

United States - English - NLM (National Library of Medicine)

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Active ingredient:
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077), ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)
Available from:
FoodHold U.S.A LLC
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 counterclockwise - 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
Authorization number:
41520-653-15

CAREONE EYE DROPS SEASONAL RELIEF- tetrahydrozoline hcl and zinc sulfate solution/

drops

FoodHold U.S.A 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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Careone Eye Drops Seasonal Relief 0.5 oz (NBE Visine AC) 86533 2018

Active Ingredients Purposes

Tetrahydrozoline HCl 0.05%.......Eye redness reliever

Zinc sulfate 0.25%......................Eye astringent

Uses

for temporary relief of discomfort and redness of the eye due to minor eye irritations

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 (1-

800-222-1222) right away.

Directions

to open bottle, push cap down and twist counterclockwise

put 1 to 2 drops in the affected eye(s) up to 4 times daily

children under 6 years of age: ask a doctor

some users may exprience a brief tingling sensation

store between 15-25ºC (59-77ºF)

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate

Questions or comments?

Call 1-877-846-9949

Distributed by:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

CAREONE EYE DROPS SEASONAL RELIEF

tetrahydrozoline hcl and zinc sulfate solution/ drops

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41520 -6 53

Route of Administration

OPHTHALMIC

FoodHold U.S.A LLC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TETRAHYDRO ZO LINE HYDRO CHLO RIDE (UNII: 0 YZT43HS7D)

(TETRAHYDROZOLINE - UNII:S9 U0 25Y0 77)

TETRAHYDROZOLINE

HYDROCHLORIDE

0 .5 mg

in 1 mL

ZINC SULFATE (UNII: 8 9 DS0 H9 6 TB) (ZINC CATION - UNII:13S1S8 SF37)

ZINC SULFATE

2.5 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

BO RIC ACID (UNII: R57ZHV8 5D4)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41520 -6 53-15

1 in 1 BOX

10 /0 1/20 18

1

15 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt349

0 9 /26 /20 18

Labeler -

FoodHold U.S.A LLC (809183973)

Revised: 5/2019

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