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.

----------

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

Eye09

I-DROPS ARTIFICIAL TEARS 
hypromellose, naphazoline hydrochloride, polysorbate 80, zinc sulfate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73921-009
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO) HYPROMELLOSE, UNSPECIFIED2 mg  in 1 mL
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.25 mg  in 1 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H) (POLYSORBATE 80 - UNII:6OZP39ZG8H) POLYSORBATE 805 mg  in 1 mL
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73921-009-151 in 1 CARTON04/01/202102/08/2023
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34904/01/202102/08/2023
Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)
Establishment
NameAddressID/FEIBusiness Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED860186917manufacture(73921-009)

Revised: 2/2023
Document Id: f42b5aca-6d90-2a78-e053-2a95a90a342a
Set id: 03ae5fee-1901-44e5-b0b2-3c4311e44db1
Version: 2
Effective Time: 20230208
 
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED