i-Oint LUBRICANT EYE OINTMENT

i-Oint LUBRICANT EYE by

Drug Labeling and Warnings

i-Oint LUBRICANT EYE by is a Otc medication manufactured, distributed, or labeled by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

I-OINT LUBRICANT EYE- mineral oil, white petrolatum ointment 
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

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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i-Oint LUBRICANT EYE OINTMENT

Drug Facts

ACTIVE INGREDIENT

Mineral Oil 3%

White Petrolatum 94%

PURPOSE

lubricant

INDICATIONS & USAGE SECTION

For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

WARNINGS

For external use only.

OTC - DO NOT USE SECTION
If you are sensitive to any ingredient in this product.

OTC - WHEN USING SECTION
Remove contact lenses before using
To avoid contamination, do not touch tip of container to any surface
replace cap after using.

OTC - STOP USE SECTION AND ASK A DOCTOR IF
you feel eye pain, changes in vision occur, Redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours.

Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

OTHER INFORMATION

Store at 8°-27°C (46°-80°F).

INACTIVE INGREDIENT

Anhydrous Liquid Lanolin 3%.

Questions or comments?

1-800-572-6632 between 9am and 4 pm EST, Monday-Friday.

Intensive Ointment for Dry Eyes

Sterile

FOR OPHTHALMIC USE ONLY

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

I-OINT LUBRICANT EYE 
mineral oil, white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-039
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	30 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	940 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-039-35	1 in 1 CARTON	04/01/2021	02/08/2023
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	04/01/2021	02/08/2023

Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Establishment
Name	Address	ID/FEI	Business Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture(73921-039)

Revised: 2/2023

Document Id: f42adf39-8452-9387-e053-2995a90a06fb

34390-5

Set id: 419f7095-706e-4dcd-a670-1ef772c08cc4

Version: 2

Effective Time: 20230208