RETAINE MGD- mineral oil emulsion 
OCuSOFT, Inc.

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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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

When using this product

Stop use and ask a doctor if

KEEP OUT OF THE REACH OF CHILDREN

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

Directions

Other Information

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

Carton Label
RETAINE MGD 
mineral oil emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54799-917
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP) (LIGHT MINERAL OIL - UNII:N6K5787QVP) LIGHT MINERAL OIL2 mg  in 0.4 mL
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL2 mg  in 0.4 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54799-917-3030 in 1 CONTAINER01/05/2012
10.4 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
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/FEIBusiness Operations
Excelvision274234566pack(54799-917) , manufacture(54799-917)
Establishment
NameAddressID/FEIBusiness Operations
Servipac571772875pack(54799-917)

Revised: 1/2023
Document Id: b44f24fa-6384-4fd3-9070-f3f195260f9d
Set id: 06f57d46-96c7-4093-84aa-874ff4b2131d
Version: 5
Effective Time: 20230112
 
OCuSOFT, Inc.