QUALITY CHOICE ARTIFICIAL TEARS- polyvinyl alcohol, povidone solution/ drops

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

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Active ingredient:
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990), POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)
Available from:
Chain Drug Marketing Association, Inc.
Administration route:
OPHTHALMIC
Prescription type:
OTC DRUG
Therapeutic indications:
​Purpose Polyvinyl alcohol: Eye Lubricant Povidone: Eye Lubricant Uses : - for use as a protectant against further irritation or to relieve dryness of the eye - for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun
Authorization status:
OTC monograph final
Authorization number:
63868-223-15

QUALITY CHOICE ARTIFICIAL TEARS- polyvinyl alcohol, povidone solution/ drops

Chain Drug Marketing Association, 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.

----------

Active ingredients

Polyvinyl alcohol 0.5%

Povidone 0.6%

Purpose

Polyvinyl alcohol: Eye Lubricant

Povidone: Eye Lubricant

Uses:

for use as a protectant against further irritation or to relieve dryness of the eye

for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or

Warnings

For external use only

Do not use this productif solution changes color or becomes cloudy

Stop use and ask a doctor if you experience

eye pain

changes in vision

continued redness or irritation of the eye or if the condition worsens or persists for more than 72

hours

When using this product

to avoid contamination, do not touch tip of container to any surface

replace cap after using. Keep container tightly closed

remove contact lens before using

Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison

Control Center immediately.

Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

Tamper Evident. Do not use this product if imprinted neckband is missing or broken.

RETAIN THIS CARTON FOR FUTURE REFERENCE

Store at 15°-30°C (59°-86°F)

Inactive ingredients

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium

bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, and sodium phosphate

monobasic

QUALITY CHOICE ARTIFICIAL TEARS

polyvinyl alcohol, povidone solution/ drops

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 38 6 8 -223

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 ) (POLYVINYL ALCOHOL -

UNII:532B59 J9 9 0 )

POLYVINYL

ALCOHOL

50 0 mg

in 10 0 mL

PO VIDO NE (UNII: FZ9 8 9 GH9 4E) (POVIDONE - UNII:FZ9 8 9 GH9 4E)

POVIDONE

6 0 0 mg

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

Chain Drug Marketing Association, Inc.

DEXTRO SE (UNII: IY9 XDZ35W2)

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

PO TASSIUM CHLO RIDE (UNII: 6 6 0 YQ9 8 I10 )

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

SO DIUM PHO SPHATE, DIBASIC (UNII: GR6 8 6 LBA74)

SO DIUM PHO SPHATE, MO NO BASIC (UNII: 39 8 0 JIH2SW)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 38 6 8 -223-

1 in 1 BOX

0 7/26 /20 19

1

15 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

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 7/26 /20 19

Labeler -

Chain Drug Marketing Association, Inc. (011920774)

Registrant -

KC Pharmaceuticals, Inc. (174450460)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

KC Pharmaceuticals, Inc.

174450 46 0

manufacture(6 38 6 8 -223) , label(6 38 6 8 -223) , pack(6 38 6 8 -223)

Revised: 7/2019

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