i-Drops LUBRICANT EYE DROPS

i-Drops LUBRICANT EYE DROPS by

Drug Labeling and Warnings

i-Drops LUBRICANT EYE DROPS 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-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.

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i-Drops LUBRICANT EYE DROPS

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-006-15	1 in 1 CARTON	04/01/2021	02/08/2023
1		15 mL in 1 BOTTLE, DROPPER; 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(73921-006)

Revised: 2/2023

Document Id: f42b6382-057f-0e63-e053-2a95a90a211c

34390-5

Set id: 22e8e404-7ecb-4f2d-bfc7-6ce8d4a333e7

Version: 2

Effective Time: 20230208