i-Drops DECONGESTANT EYE DROPS

i-Drops DECONGESTANT EYE DROPS by

Drug Labeling and Warnings

i-Drops DECONGESTANT 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 DECONGESTANT EYE DROPS- glycerin, naphazoline hydrochloride 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 DECONGESTANT EYE DROPS

DRUG FACTS

ACTIVE INGREDIENT

Glycerin 0.5%
Naphazoline hydrochloride 0.03%

PURPOSE

Lubricant
Redness reliever

Uses

For the relief of redness of the eye due to minor eye irritations

For the temporary relief of burning and irritation due to dryness of the eye

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

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 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 or persists 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 or 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 this product if neckband is missing or broken

Inactive ingredients

Benzalkonium chloride, Boric acid, Edetate disodium, Purified water, Sodium borate.

Questions?

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

Eye Allergy Relief

Soothes puffy itchy / red watering eyes

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

I-DROPS DECONGESTANT EYE DROPS 
glycerin, naphazoline hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-008
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	5 mg  in 1 mL
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-008-15	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(73921-008)

Revised: 2/2023

Document Id: f42b6382-058d-0e63-e053-2a95a90a211c

34390-5

Set id: 64a323d2-6c68-4165-8f3b-fa03b919b247

Version: 2

Effective Time: 20230208