I-Drop MGD by I-MED PHARMA I-Drop® MGD

I-Drop MGD by

Drug Labeling and Warnings

I-Drop MGD by is a Otc medication manufactured, distributed, or labeled by I-MED PHARMA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

I-DROP MGD- glycerin liquid 
I-MED PHARMA

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-Drop® MGD

Drug Facts

Active ingredient

Glycerin (0.30%)

Purpose

Lubricant

Uses

• For the temporary relief of burning and irritation due to dryness of the eye.
• For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.
• For use as a protectant against further irritation or to relieve dryness of the eye.

Warnings

For external use only.

Do not use

• If solution changes color or becomes cloudy.
• If you are sensitive to any of the ingredients.
• With contact lenses.

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.
• To avoid contamination, do not touch tip of container to any surface.
• Replace cap after using.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Remove contact lenses.
• Remove cap and tamper-proof seal.
• Tilt bottle and instill 1 or 2 drops in the affected eye(s) as needed.
• Replace cap tightly after use.

Other information

• Do not use if seal on the carton is broken.
• Protect from light and freezing.
• Store at or below 77°F/25°C.
• Keep this carton for full product information.

Inactive ingredients

Phosphorylcholine, Sodium chloride, Sodium hyaluronate, Sodium phosphate, Water.

Questions?

In the USA call (800) 463-1008.

Distributed by
I-MED Pharma® USA
1034 44th Dr #2
Long Island City, NY
11101, USA

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Box

N13105-1209-1

I-DROP®
MGD

GLYCERIN LUBRICANT
EYE DROPS

FOR TEMPORARY RELIEF DUE
TO DRYNESS OF THE EYES

Preservative-Free
Long-Lasting Hydration
Lipid Layer Enhancer to
Reduce Tear Evaporation

STERILE

0.34 fl oz (10 mL)

I-MED
PHARMA

I-DROP MGD 
glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13105-1209
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Water (UNII: 059QF0KO0R)
Sodium Chloride (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)
Phosphorylcholine (UNII: BRP7TI555O)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13105-1209-1	1 in 1 BOX	11/04/2021	08/15/2022
1		10 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	11/04/2021	08/15/2022

Labeler - I-MED PHARMA (249008772)

Revised: 8/2022

Document Id: c6f1ecea-d0d4-48a9-aecc-be7c63f53053

34390-5

Set id: e02e7992-cc07-45aa-b1c9-f84411ca123c

Version: 2

Effective Time: 20220816

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