i-Drops ARTIFICIAL TEARS by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED i-Drops ARTIFICIAL TEARS

i-Drops ARTIFICIAL TEARS by

Drug Labeling and Warnings

i-Drops ARTIFICIAL TEARS 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 ARTIFICIAL TEARS- hypromellose, naphazoline hydrochloride, polysorbate 80, zinc sulfate 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 ARTIFICIAL TEARS

DRUG FACTS

ACTIVE INGREDIENT

Hypromellose 0.20%
Naphazoline Hydrochloride 0.025%
Polysorbate 80 0.50%
Zinc Sulfate 0.25%

PURPOSE

Lubricant
Redness Reliever
Lubricant
Lubricant

Uses

 For use as a protectant against further irritation or to relieve dryness of the eye.

For the temporary relief of burning & irritation due to the dryness of the eye.

Relieves redness of the eye due to minor eye irritations.

Warnings

For external use only.

Do not use if solution changes color or becomes cloudy.

Ask a doctor before use if you have narrow angle glaucoma

When using this product:  To avoid contamination, do not touch tip of container to any surface. Replace cap after using.  Overuse of this product may produce increased redness of the eye.  Pupils may become enlarged temporarily.

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
Symptoms last for more than 72 hours

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

Directions

Instill 1 to 2 drops in the affected eye(s) up to four times daily.

Other information

Store at room temperature.

Remove contact lenses before using.

Tamper Evident: Do not use if neckband on bottle is broken or missing.

Inactive ingredients

Calcium chloride, Citric acid, Edetate disodium, Magnesium chloride, Potassium chloride, Purified water, Sodium citrate, Sodium chloride and Sorbic acid.

Questions?

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

Relieve dryness of the eye

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

I-DROPS ARTIFICIAL TEARS 
hypromellose, naphazoline hydrochloride, polysorbate 80, zinc sulfate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-009
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO)	HYPROMELLOSE, UNSPECIFIED	2 mg  in 1 mL
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.25 mg  in 1 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H) (POLYSORBATE 80 - UNII:6OZP39ZG8H)	POLYSORBATE 80	5 mg  in 1 mL
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-009-15	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(73921-009)

Revised: 2/2023

Document Id: f42b5aca-6d90-2a78-e053-2a95a90a342a

34390-5

Set id: 03ae5fee-1901-44e5-b0b2-3c4311e44db1

Version: 2

Effective Time: 20230208