RETAINE MGD- mineral oil emulsion

retaine MGD by

Drug Labeling and Warnings

retaine MGD by is a Otc medication manufactured, distributed, or labeled by OCuSOFT, Inc., Excelvision, Servipac. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Light Mineral Oil (0.5)................................Emollient

Mineral Oil (0.5%).....................................Emollient

Uses

For use as a protectant against further irritation or to relieve dryness of the eye.

Warnings

For use in the eyes only.

Do not use

• if this product changes color.

When using this product

• do not touch tip of container to any surface to avoid contamination.
• do not reuse once opened.

Stop use and ask a doctor if

• you feel eye pain or changes in vision, continued redness or irritation of the eye.
• the condition worsens or persists for more than 72 hours.

KEEP OUT OF THE REACH OF CHILDREN

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

Directions

• Shake well before using.
• Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

Other Information

• Use only if printed tamper seals on top and bottom flaps are intact.
• Drops appear as a milky white solution.
• Store between 15 o-30 oC (59 o-86 oF).

Inactive ingredients

Cetalkonium chloride, glycerol, poloxamer 188, tris hydrochloride, tromethamine, tyloxapol, water for injection.

Questions?

Call (800)233-5469 M-F 8:30AM-5:00PM CST or visit www.retainebrand.com

PURPOSE

Emollient

PRINCIPAL DISPLAY PANEL - 30 sterile Single-Dose Containers Carton

INGREDIENTS AND APPEARANCE

RETAINE MGD 
mineral oil emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54799-917
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP) (LIGHT MINERAL OIL - UNII:N6K5787QVP)	LIGHT MINERAL OIL	2 mg  in 0.4 mL
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	2 mg  in 0.4 mL

Inactive Ingredients
Ingredient Name	Strength
CETALKONIUM CHLORIDE (UNII: 85474O1N9D)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 188 (UNII: LQA7B6G8JG)
TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E)
TROMETHAMINE (UNII: 023C2WHX2V)
TYLOXAPOL (UNII: Y27PUL9H56)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54799-917-30	30 in 1 CONTAINER	01/05/2012
1		0.4 mL in 1 VIAL, SINGLE-DOSE; 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	01/05/2012

Labeler - OCuSOFT, Inc. (174939207)

Registrant - OCuSOFT, Inc. (174939207)

Establishment
Name	Address	ID/FEI	Business Operations
Excelvision		274234566	pack(54799-917) , manufacture(54799-917)

Establishment
Name	Address	ID/FEI	Business Operations
Servipac		571772875	pack(54799-917)