LEADER ULTRA LUBRICATING EYE DROPS- polyethylene glycol, propylene glycol liquid

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

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Active ingredient:
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ), PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)
Available from:
Cardinal Health
Administration route:
OPHTHALMIC
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Polyethylene glycol 400............. Lubricant Propylene glycol............ Lubricant Uses • for the temporary relief of burning and irritation due to dryness of the eye
Authorization status:
OTC monograph final
Authorization number:
70000-0457-1, 70000-0457-2

LEADER ULTRA LUBRICATING EYE DROPS- polyethylene glycol, propylene glycol liquid

Cardinal Health

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

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Purpose

Polyethylene glycol 400............. Lubricant

Propylene glycol............ Lubricant

Uses

for the temporary relief of burning and irritation due to dryness of the eye

Warnings

For external use only

Do not use

if this product changes color or becomes cloudy

if you are sensitive to any ingredient in this product

When using this product

do not touch the 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(s) gets worse or lasts more than 72 hours

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

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

Children under 6 years of age: ask a doctor

Other information

RETAIN THIS CARTON FOR FUTURE REFERENCE

Store at room temperature

Inactive ingredients

Aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium

chloride, purified water, sodium chloride, sorbitol

LEADER ULTRA LUBRICATING EYE DROPS

polyethylene glycol, propylene glycol liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 0 0 -0 457

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ) (POLYETHYLENE GLYCOL 40 0 -

UNII:B6 9 78 9 4SGQ)

POLYETHYLENE

GLYCOL 40 0

0 .4 g

in 10 0 mL

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3) (PROPYLENE GLYCOL - UNII:6 DC9 Q16 7V3)

PROPYLENE GLYCOL

0 .3 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

AMINO METHYLPRO PANO L (UNII: LU49 E6 6 26 Q)

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

Cardinal Health

BO RIC ACID (UNII: R57ZHV8 5D4)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

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

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO RBITO L (UNII: 50 6 T6 0 A25R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:70 0 0 0 -

0 457-1

1 in 1 BOX

0 2/19 /20 19

1

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

Pro duc t

2

NDC:70 0 0 0 -

0 457-2

2 in 1 BOX

0 4/30 /20 19

2

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 2/19 /20 19

Labeler -

Cardinal Health (097537435)

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(70 0 0 0 -0 457) , pack(70 0 0 0 -0 457) , label(70 0 0 0 -0 457)

Revised: 4/2019

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