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- polyvinyl alcohol 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

Polyvinyl Alcohol 1.4%

PURPOSE

Eye lubricant

Uses

For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

Warnings

Do not use if seal on the bottle neck is broken or missing.

Do not use if solution changes color or becomes cloudy.

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, Changes in vision,
Continued redness or irritation of the eye, or if 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) as needed.

Other information

Store at 20° to 25°C (68° to 77°F)

[see USP Controlled Room Temperature].

Store away from heat.

Protect from freezing.

Keep tightly closed. RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Benzalkonium Chloride 0.005%, Edetate Disodium, Sodium Chloride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Purified water, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.

Questions?

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

Lubricant Eye Drops

Prevents Irritation and Relieves 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

Eye01

I-DROPS ARTIFICIAL TEARS 
polyvinyl alcohol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73921-001
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED14 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73921-001-151 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(73921-001)

Revised: 2/2023
 

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