LEADER LUBRICANT EYE- mineral oil, and white petrolatum ointment

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

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Active ingredient:
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP), PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
Available from:
Cardinal Health
Administration route:
OPHTHALMIC
Prescription type:
OTC DRUG
Therapeutic indications:
Uses - For the temporary relief of burning, irritation, and discomfort due to dryness or the eye or exposure to wind or sun. - May be used as a protectant against further irritation Stop use and ask a doctor if: - You experience eye pain, changes in vision, continued redness or irritation of the eye. - The condition worsens or persists for more than 72 hours. . Directions • Wash your hands. • Pull down the lower lid of the affected eye and gently apply a small amount (1/4”) of ointment to the inside of the eyelid.
Authorization status:
OTC monograph final
Authorization number:
70000-0513-1

LEADER LUBRICANT EYE- mineral oil, and white petrolatum ointment

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.

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Leader Lubricant Eye Ointment

Active ingredients Purpose

Mineral oil 42.5%........................................................ Eye Lubricant

White petrolatum 57.3%............................................. Eye Lubricant

Uses

For the temporary relief of burning, irritation, and discomfort due to dryness or the eye or exposure

to wind or sun.

May be used as a protectant against further irritation

Warnings

For external use only.

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

Keep tube tightly closed.

Stop use and ask a doctor if:

You experience eye pain, changes in vision, continued redness or irritation of the eye.

The condition worsens or persists for more than 72 hours. .

Keep out of reach of children.

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

Directions

Wash your hands.

Pull down the lower lid of the affected eye and gently apply a small amount (1/4”) of ointment to the

inside of the eyelid.

Other information

store away from heat

protect from freezing

use before expiration date on the tube

store at 59°-86° (15°-30°)

Inactive ingredient

lanolin alcohol

Directions

Wash your hands.

Pull down the lower lid of the affected eye and gently apply a small amount (1/4”) of ointment to the

inside of the eyelid.

LEADER LUBRICANT EYE

mineral oil, and white petrolatum ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 0 0 -0 513

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Cardinal Health

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MINERAL O IL (UNII: T5L8 T28 FGP) (MINERAL OIL - UNII:T5L8 T28 FGP)

MINERAL OIL

425 mg in 1 g

PETRO LATUM (UNII: 4T6 H12BN9 U) (PETROLATUM - UNII:4T6 H12BN9 U)

PETROLATUM

573 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

LANO LIN ALCO HO LS (UNII: 8 8 4C3FA9 HE)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 0 0 0 -0 513-1

1 in 1 BOX

0 8 /30 /20 19

1

3.5 g in 1 TUBE; 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 8 /30 /20 19

Labeler -

Cardinal Health (097537435)

Revised: 11/2019

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