OTC Medication Information: I-Drops LUBRICANT EYE DROPS

I-DROPS LUBRICANT EYE DROPS- glycerin solution/ drops
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 INGREDIENT

Glycerin 1.0%

PURPOSE

lubricant

Uses

• For use as a lubricant to prevent 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.

Warnings

For external use only

Do not use  if solution changes color or becomes cloudy

When using this product
• 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 • You experience changes in vision • You experience continued redness or irritation of the eye • The condition worsens or persists for more than 72 hours.

Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center.

Directions

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

Other information

store in the refrigerator

do not freeze

store in dark, cool place away from sunlight

once open, discard container and any content after 30 days

use before expiration date marked on container

prior to drop instillation, contact lenses should be removed and reinserted after 10 minutes

Inactive ingredients

Boric acid, Citric acid, Hypromellose, Potassium bicarbonate, Purified benzyl alcohol, Sterile water

Questions?

Call toll-free 1-800-572-6632, weekdays, 7:00 AM — 5:30 PM EST.

Immediate relief for dry eyes

Long lasting moisture rich formula

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 — INDIA.

www.global-pharma.com

Packaging

I-DROPS LUBRICANT EYE DROPS glycerin solution/ drops

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73921-006 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (GLYCERIN) GLYCERIN 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BORIC ACID CITRIC ACID MONOHYDRATE HYPROMELLOSE, UNSPECIFIED POTASSIUM BICARBONATE BENZYL ALCOHOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73921-006-15 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER 1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (73921-006-15)

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 (73921-006)

Revised: 03/2021 GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED