OTC Medication Information: I-Drops DECONGESTANT EYE DROPS

I-DROPS DECONGESTANT EYE DROPS- glycerin and 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.

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (GLYCERIN) GLYCERIN 5 mg in 1 mL NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE 0.3 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE BORIC ACID EDETATE DISODIUM WATER SODIUM BORATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73921-008-15 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER 1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (73921-008-15)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 04/01/2021

Labeler — GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Establishment
Name	Address	ID/FEI	Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture (73921-008)

Revised: 03/2021 GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED