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retaine MGD

Medically reviewed on Jul 19, 2018

Dosage form: emulsion
Ingredients: LIGHT MINERAL OIL 2mg in 0.4mL, MINERAL OIL 2mg in 0.4mL
Labeler: OCuSOFT, Inc.
NDC Code: 54799-917

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 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

Emollient

PRINCIPAL DISPLAY PANEL - 30 sterile Single-Dose Containers Carton

RETAINE MGD 
mineral oil emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54799-917
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIGHT MINERAL OIL (LIGHT MINERAL OIL) LIGHT MINERAL OIL2 mg  in 0.4 mL
MINERAL OIL (MINERAL OIL) MINERAL OIL2 mg  in 0.4 mL
Inactive Ingredients
Ingredient NameStrength
CETALKONIUM CHLORIDE 
GLYCERIN 
POLOXAMER 188 
TROMETHAMINE HYDROCHLORIDE 
TROMETHAMINE 
TYLOXAPOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:54799-917-3030 VIAL, SINGLE-DOSE in 1 CONTAINER
10.4 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/05/2012
Labeler - OCuSOFT, Inc. (174939207)
Registrant - OCuSOFT, Inc. (174939207)
Establishment
NameAddressID/FEIOperations
Excelvision274234566pack(54799-917), manufacture(54799-917)
Establishment
NameAddressID/FEIOperations
Servipac571772875pack(54799-917)

 
OCuSOFT, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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