OTC Medication Information: I-Oint LUBRICANT EYE

I-OINT LUBRICANT EYE- mineral oil and 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.

Drug Facts

ACTIVE INGREDIENTS

Mineral Oil 15%

White Petrolatum 83%

PURPOSE

Eye lubricant

USES

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

WARNINGS

• For external use only.

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

• Replace cap after using.

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.

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

Questions or comments?

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

DIRECTIONS

Pull down lower lid of the affected eye(s) and apply small amount (one-fourth inch) of ointment to the inside of the eyelid, one or more times daily, or as directed by a doctor.

OTHER INFORMATION

• Store at 20° to 25°C (68° to 77°F) [see USP controlled Room Temperature].

• Store away from heat.

• Protect from freezing.

• Keep tightly closed.

• See crimp for Control Number and Expiration Date.

• RETAIN THIS CARTON FOR FUTURE REFERENCE.

INACTIVE INGREDIENT

Lanolin 2%

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:73921-041 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (MINERAL OIL) MINERAL OIL 150 mg in 1 g PETROLATUM (PETROLATUM) PETROLATUM 830 mg in 1 g

Inactive Ingredients Ingredient Name Strength LANOLIN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73921-041-35 1 TUBE in 1 CARTON contains a TUBE 1 3.5 g in 1 TUBE This package is contained within the CARTON (73921-041-35)

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

Labeler — GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Establishment
Name	Address	ID/FEI	Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture (73921-041)

Revised: 03/2021 GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED