I-DEFENSE by I-MED Pharma Inc.

I-DEFENSE by

Drug Labeling and Warnings

I-DEFENSE by is a Otc medication manufactured, distributed, or labeled by I-MED Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

I-DEFENSE- petrolatum, lanolin, and mineral oil ointment 
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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Directions:

• Remove contact lenses.
• Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

For external use only.

Stop use and ask a doctor if

• You are sensitive to any of the ingredients.
• 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.
• Do not use with contact lenses.
• To avoid contamination, do not touch tip of container to any surface.
• Replace cap after using.

Hyaluronan, Phosphate buffers, Potassium sorbate, Sodium chloride, Sodium hydroxymethylglycinate, Water.

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

Other information

• Do not use if seal on the carton is broken.
• Store between 9° to 25°C (48° to 77°F).
• Keep this carton for full product information.
• For use within 8 weeks of opening.

• Active Ingredients: Purpose
• Lanolin (1%): Lubricant
• Mineral oil (38%): Lubricant
• Petrolatum (38%): Lubricant

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

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

PRINCIPAL DISPLAY PANEL - 5 g Tube Box

I-DEFENSE

Lubricant Eye Ointment

FOR NIGHTTIME PROTECTION OF DRY EYES

Immediate, Long-Lasting Lubrication

Nighttime Use

STERILE

Net wt.

0.18 oz (5 g)

I-MED

PHARMA

Questions?

In the USA call (800) 463-1008.

Distributed by

I-MED Pharma US

1034 44th Dr #2

Long Island City

I-DEFENSE 
petrolatum, lanolin, and mineral oil ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13105-1280
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	1917 mg  in 5 g
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	435 mg  in 5 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	1917 mg  in 5 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13105-1280-1	1 in 1 BOX	09/01/2021	12/01/2022
1		5 g in 1 TUBE; 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	09/01/2021	12/01/2022

Labeler - I-MED PHARMA (249008772)

Revised: 12/2022

Document Id: e191492f-c36d-422e-bbed-71725e09b0f4

34390-5

Set id: 58dc85e4-5db5-4c6f-bda8-1e5164223d6b

Version: 15

Effective Time: 20221208

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